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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FDA 510(k) K210943 — FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210943. Device: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App). Applicant as listed: Abbott Diabetes Care, Inc.. Decision date: 2021-11-22.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K211342. Device: Sofia 2 Campylobacter FIA. Applicant as listed: Quidel Corporation. Decision date: 2021-11-23.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203248. Device: Albumin BCG2. Applicant as listed: Abbott Ireland Diagnostics Division. Decision date: 2021-11-23.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212223. Device: Atellica CH Enzymatic Creatinine_3 (ECre3). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2021-11-24.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212176. Device: CINtec Histology. Applicant as listed: Ventana Medical Systems, Inc.. Decision date: 2021-12-10.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212221. Device: Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer. Applicant as listed: Diazyme Laboratories, Inc.. Decision date: 2021-12-13.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210212. Device: Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair. Applicant as listed: Psychemedics Corporation. Decision date: 2021-12-15.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K211539. Device: Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL. Applicant as listed: Thermo Fisher Scientific. Decision date: 2021-12-15.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203695. Device: NObreath®. Applicant as listed: Bedfont Scientific, Ltd.. Decision date: 2021-12-17.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193081. Device: Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit. Applicant as listed: Rheonix, Inc.. Decision date: 2021-12-17.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203741. Device: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml. Applicant as listed: Thermo Fisher Scientific. Decision date: 2021-12-20.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203647. Device: SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay. Applicant as listed: Immunalysis Corporation. Decision date: 2021-12-22.
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.