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 K212248. Device: GlucoLeader Enhance 2 Blood Glucose Monitoring System. Applicant as listed: Hmd Biomedical, Inc.. Decision date: 2022-08-29.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213718. Device: SOL-GUARD Safety Pull Button Collection Set. Applicant as listed: Sol-Millennium Medical, Inc.. Decision date: 2022-08-30.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222558. Device: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set. Applicant as listed: Centers for Disease Control and Prevention. Decision date: 2022-08-30.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221871. Device: Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx. Applicant as listed: Healstone Biotech, Inc.. Decision date: 2022-08-30.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210973. Device: MammaPrint FFPE NGS Kit. Applicant as listed: Agendia, Inc.. Decision date: 2022-09-08.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K211648. Device: Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay. Applicant as listed: Diazyme Laboratories, Inc.. Decision date: 2022-09-08.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212147. Device: Simplexa COVID-19 Direct. Applicant as listed: Diasorin Molecular, LLC. Decision date: 2022-09-13.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201049. Device: FINDER G6PD. Applicant as listed: Baebies, Inc.. Decision date: 2022-09-14.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220176. Device: Elecsys AFP. Applicant as listed: Roche Diagnostics. Decision date: 2022-09-15.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203336. Device: Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30. Applicant as listed: Oxoid Limited (Part of Thermo Fisher Scientific). Decision date: 2022-09-15.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220134. Device: cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH. Applicant as listed: Roche Diagnostics. Decision date: 2022-09-16.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220607. Device: BD MAX Enteric Viral Panel. Applicant as listed: Becton, Dickinson and Company. Decision date: 2022-09-21.
Source: api.fda.gov · Retrieved 2026-10-29
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.