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 K203564. Device: SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay. Applicant as listed: Immunalysis Corporation. Decision date: 2021-12-22.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210976. Device: Curian Campy. Applicant as listed: Meridian Bioscience, Inc.. Decision date: 2021-12-23.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193407. Device: Contour® next GEN Blood Glucose Monitoring System. Applicant as listed: Ascensia Diabetes Care. Decision date: 2021-12-23.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202101. Device: GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2. Applicant as listed: Accriva Diagnostics, Inc.. Decision date: 2021-12-29.
Source: api.fda.gov · Retrieved 2026-10-19
FDA 510(k) K211499 — 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K211499. Device: 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related). Applicant as listed: 23AndMe, Inc.. Decision date: 2022-01-06.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212576. Device: MDx-Chex for BCID2. Applicant as listed: Streck, Inc.. Decision date: 2022-01-19.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213211. Device: Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System. Applicant as listed: Carolina Liquid Chemistries Corp.. Decision date: 2022-01-27.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203772. Device: Omnipod 5 SmartBolus Calculator. Applicant as listed: Insulet Corporation. Decision date: 2022-01-27.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212648. Device: VITROS Immunodiagnostic Products CK-MB Reagent Pack. Applicant as listed: Ortho Clinical Diagnostics. Decision date: 2022-01-28.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203272. Device: Alltest Pregnancy Rapid Combo Test Cassette. Applicant as listed: Hangzhou AllTest Biotech Co., Ltd.. Decision date: 2022-01-31.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201403. Device: NATtrol BD MAX Vaginal Panel External Controls. Applicant as listed: Zeptometrix. Decision date: 2022-02-02.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212724. Device: BD Vacutainer UltraTouch Push Button Blood Collection Set. Applicant as listed: Becton, Dickinson and Company. Decision date: 2022-02-04.
Source: api.fda.gov · Retrieved 2026-10-30
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.