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 K211685. Device: Elecsys Testosterone II. Applicant as listed: Roche Diagnostics. Decision date: 2022-05-06.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K211840. Device: Sight OLO. Applicant as listed: S.D. Sight Diagnostics , Ltd.. Decision date: 2022-05-09.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203429. Device: Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System. Applicant as listed: Cepheid. Decision date: 2022-05-09.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203527. Device: Immunalysis Tapentadol Urine HEIA. Applicant as listed: Lmmunalysis Corporation. Decision date: 2022-05-09.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210585. Device: BD CTGCTV2. Applicant as listed: Becton, Dickinson and Company. Decision date: 2022-05-10.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210596. Device: ARCHITECT Toxo IgG. Applicant as listed: Abbott Laboratories. Decision date: 2022-05-19.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K211256. Device: Disposable Sampler Viral Transport Media. Applicant as listed: Wuxi Nest Biotechnology Co., Ltd.. Decision date: 2022-05-20.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200788. Device: Assure Titanium Blood Glucose Monitoring System. Applicant as listed: Arkray, Inc.. Decision date: 2022-05-23.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210633. Device: Amylase2. Applicant as listed: Abbott Ireland Diagnostics Division. Decision date: 2022-05-26.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212132. Device: FreeStyle Libre 3 Continuous Glucose Monitoring System. Applicant as listed: Abbott Diabetes Care, Inc.. Decision date: 2022-05-26.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203771. Device: Urea Nitrogen2. Applicant as listed: Abbott Ireland Diagnostics Division. Decision date: 2022-05-31.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200754. Device: Hemosure Accu-Reader A100. Applicant as listed: W.H.P.M., Inc.. Decision date: 2022-06-02.
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.