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 K231601. Device: FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2. Applicant as listed: Sebia. Decision date: 2024-02-23.
Fuente: api.fda.gov · Consultado el 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232075. Device: StatStrip Glucose Hospital Meter System. Applicant as listed: Nova Biomedical Corporation. Decision date: 2024-02-23.
Fuente: api.fda.gov · Consultado el 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232522. Device: ARK Levetiracetam II Assay. Applicant as listed: Ark Diagnostics, Inc.. Decision date: 2024-02-27.
Fuente: api.fda.gov · Consultado el 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232791. Device: Access Intact PTH. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2024-03-01.
Fuente: api.fda.gov · Consultado el 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233410. Device: LIAISON PLEX Respiratory Flex Assay. Applicant as listed: Luminex Corporation. Decision date: 2024-03-01.
Fuente: api.fda.gov · Consultado el 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240351. Device: FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine). Applicant as listed: Assure Tech., LLC. Decision date: 2024-03-06.
Fuente: api.fda.gov · Consultado el 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240273. Device: Access Free T4. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2024-03-06.
Fuente: api.fda.gov · Consultado el 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232781. Device: Safety Sliding Blood Collection Set. Applicant as listed: Jiangsu Caina Medical Co.,Ltd. Decision date: 2024-03-07.
Fuente: api.fda.gov · Consultado el 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231904. Device: Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard. Applicant as listed: Co-Innovation Biotech Co., Ltd.. Decision date: 2024-03-08.
Fuente: api.fda.gov · Consultado el 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231758. Device: NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2). Applicant as listed: Luminex Molecular Diagnostics, Inc.. Decision date: 2024-03-11.
Fuente: api.fda.gov · Consultado el 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233946. Device: IMMULITE® 2000 BR-MA. Applicant as listed: Siemens Healthcare Diagnostics Products, Ltd.. Decision date: 2024-03-13.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K234055. Device: DEKA Loop. Applicant as listed: Deka Research and Development. Decision date: 2024-03-13.
Fuente: api.fda.gov · Consultado el 2026-10-26
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.