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 K251674. Device: Fenom Flo FeNO Monitoring System. Applicant as listed: Mgc Diagnostics Corporation. Decision date: 2025-11-26.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242976. Device: Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device. Applicant as listed: Medical Wire & Equipment Company (Bath), Ltd.. Decision date: 2025-11-26.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251058. Device: Tru Kidney Health Test Panel; Tru Analyzer. Applicant as listed: Truvian Health. Decision date: 2025-11-26.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251697. Device: Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip. Applicant as listed: ACON Laboratories, Inc.. Decision date: 2025-11-26.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251779. Device: Omnipod 5 algorithm. Applicant as listed: Insulet Corporation. Decision date: 2025-12-03.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250816. Device: ADVIA Centaur Anti-Thyroglobulin II (aTgII). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2025-12-04.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251337. Device: Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10. Applicant as listed: Thermo Fisher Scientific (Oxoid Ltd.). Decision date: 2025-12-05.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243449. Device: INFINITT DPS. Applicant as listed: Infinitt Healthcare Co., Ltd.. Decision date: 2025-12-09.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251085. Device: iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro. Applicant as listed: Ihealth Labs, Inc.. Decision date: 2025-12-12.
Source: api.fda.gov · Retrieved 2026-10-22
FDA 510(k) K251092 — iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251092. Device: iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro. Applicant as listed: Ihealth Labs, Inc.. Decision date: 2025-12-12.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250925. Device: ADVIA Centaur Cytokeratin Fragment 21-1. Applicant as listed: Fujirebio Diagnostics,Inc.. Decision date: 2025-12-16.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253839. Device: Elecsys Anti-SARS-CoV-2. Applicant as listed: Roche Diagnostics. Decision date: 2025-12-17.
Source: api.fda.gov · Retrieved 2026-10-22
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.