Published Technical Documents
Standards, guidance and application literature from the bodies and manufacturers that publish it. Every entry links to the document page itself and quotes the sentence that says what it covers.
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U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201326. Device: Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair. Applicant as listed: Psychemedics Corporation. Decision date: 2021-07-27.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203700. Device: Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30. Applicant as listed: Oxoid Limited (Part of Thermo Fisher Scientific). Decision date: 2021-07-30.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200986. Device: OPTI® B-Lac Cassette. Applicant as listed: Opti Medical Systems, Inc.. Decision date: 2021-08-02.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203246. Device: Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream). Applicant as listed: Atlas Link Technology Co., Ltd.. Decision date: 2021-08-04.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200904. Device: Tosoh Automated Glycohemoglobin Analyzer HLC-723G8. Applicant as listed: Tosoh Bioscience, Inc.. Decision date: 2021-08-05.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201089. Device: ARK Lacosamide Assay. Applicant as listed: Ark Diagnostics, Inc.. Decision date: 2021-08-05.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203136. Device: Diazyme PLAC® Test for Lp-PLA2 Activity. Applicant as listed: Diazyme Laboratories, Inc.. Decision date: 2021-08-06.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210687. Device: CONTOUR® NEXT ONE Blood Glucose Monitoring System. Applicant as listed: Ascensia Diabetes Care. Decision date: 2021-08-11.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212204. Device: Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit. Applicant as listed: Cd Diagnostics, Inc.. Decision date: 2021-08-11.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K211102. Device: FreeStyle Libre 2 Flash Glucose Monitoring System. Applicant as listed: Abbott Diabetes Care, Inc.. Decision date: 2021-08-11.
Source: api.fda.gov · Retrieved 2026-10-19
FDA 510(k) K201630 — AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201630. Device: AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests. Applicant as listed: Assure Tech. (Hangzhou) Co, Ltd.. Decision date: 2021-08-12.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210327. Device: First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup. Applicant as listed: W.H.P.M., Inc.. Decision date: 2021-08-12.
Source: api.fda.gov · Retrieved 2026-10-19
Key takeaways
Every item here is a technical document its publisher made public: a standards-body scope page, a regulator guidance document, or a manufacturer application note or journal article. The entry links to that page and quotes the sentence describing what the document covers. It is not a record of work IVDmap has done.
Target audienceImplementation teams, labs, procurement managers
Review and references
Compiled from public manufacturer materials and regulatory sources. Not independently verified and not reviewed by a named clinician.
2026-10-01
2026-10-09
professional use
Every document below is published by the body named on it, and this page links to that page. Nothing here is a record of work IVDmap has done.