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 K221765. Device: ONLINE DAT Benzodiazepines II. Applicant as listed: Roche Diagnostics. Decision date: 2022-12-23.
Fuente: api.fda.gov · Consultado el 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210017. Device: ACTOnco, ACTOnco IVD. Applicant as listed: Act Genomics. Decision date: 2022-12-23.
Fuente: api.fda.gov · Consultado el 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221990. Device: Access Total ßhCG (5th IS). Applicant as listed: Beckman Coulter, Inc.. Decision date: 2022-12-27.
Fuente: api.fda.gov · Consultado el 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223324. Device: Total Bilirubin2. Applicant as listed: Abbott Ireland Diagnostics Division. Decision date: 2022-12-29.
Fuente: api.fda.gov · Consultado el 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221693. Device: Elecsys Anti-HCV II (08837031190). Applicant as listed: Roche Diagnostics. Decision date: 2023-01-04.
Fuente: api.fda.gov · Consultado el 2026-10-29
FDA 510(k) K223635 — Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223635. Device: Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer. Applicant as listed: Sienco, Inc.. Decision date: 2023-01-04.
Fuente: api.fda.gov · Consultado el 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223931. Device: Dexcom G6 Continuous Glucose Monitoring (CGM) System. Applicant as listed: Dexcom, Inc.. Decision date: 2023-01-11.
Fuente: api.fda.gov · Consultado el 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223405. Device: Access Testosterone. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2023-01-13.
Fuente: api.fda.gov · Consultado el 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220059. Device: Biosci Inactivated Transport Medium, Biosci ITM. Applicant as listed: Shenzhen Dakewe Bio-Engineering Co., Ltd.. Decision date: 2023-01-19.
Fuente: api.fda.gov · Consultado el 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223503. Device: Access 25(OH) Vitamin D Total. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2023-01-19.
Fuente: api.fda.gov · Consultado el 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221899. Device: The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml. Applicant as listed: Thermo Fisher Scientific. Decision date: 2023-01-20.
Fuente: api.fda.gov · Consultado el 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203689. Device: Tidepool Loop. Applicant as listed: Tidepool Project. Decision date: 2023-01-23.
Fuente: api.fda.gov · Consultado el 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.