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 K241921. Device: Alinity m BKV. Applicant as listed: Abbott Molecular, Inc.. Decision date: 2025-03-24.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K244044. Device: PBC Separator with Selux AST System. Applicant as listed: Selux Diagnostics, Inc.. Decision date: 2025-03-28.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242022. Device: Access Toxo IgG. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2025-03-28.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242952. Device: INNOVANCE Antithrombin. Applicant as listed: Siemens Healthcare Diagnostic Products GmbH. Decision date: 2025-03-28.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242209. Device: UASure II Blood Uric Acid Monitoring System. Applicant as listed: Apex BioTechnology Corp.. Decision date: 2025-04-04.
Fuente: api.fda.gov · Consultado el 2026-10-24
FDA 510(k) K250727 — AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250727. Device: AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup. Applicant as listed: Hangzhou AllTest Biotech Co., Ltd.. Decision date: 2025-04-04.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242576. Device: AllTest Viral Transport Medium. Applicant as listed: Hangzhou AllTest Biotech Co., Ltd.. Decision date: 2025-04-04.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243214. Device: Dexcom G7 15 Day Continuous Glucose Monitoring System. Applicant as listed: Dexcom, Inc.. Decision date: 2025-04-09.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243346. Device: cobas liat SARS-CoV-2 v2 nucleic acid test. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2025-04-11.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242658. Device: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL. Applicant as listed: Thermo Fisher Scientific. Decision date: 2025-04-15.
Fuente: api.fda.gov · Consultado el 2026-10-24
FDA 510(k) K250803 — Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250803. Device: Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup. Applicant as listed: Anhui Deepblue Medical Technological Co., Ltd.. Decision date: 2025-04-15.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243013. Device: LIAISON PLEX Gram-Negative Blood Culture Assay. Applicant as listed: Luminex Corporation. Decision date: 2025-04-18.
Fuente: api.fda.gov · Consultado el 2026-10-24
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.