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 K201880. Device: MultiSure GK Link Blood Glucose and Ketone Monitoring System. Applicant as listed: Apex BioTechnology Corp.. Decision date: 2021-10-15.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193613. Device: Allergen-Specific IgE Assay 12 Allergen Bundle. Applicant as listed: Hitachi Chemical Diagnostics, Inc.. Decision date: 2021-10-18.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201017. Device: BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit. Applicant as listed: Geneohm Sciences Canada, Inc. (Bd Life Sciences). Decision date: 2021-10-18.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K211672. Device: MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL. Applicant as listed: Liofilchem s.r.l.. Decision date: 2021-10-20.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212427. Device: cobas Cdiff nucleic acid test for use on the cobas Liat System. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2021-10-20.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200865. Device: Piccolo Potassium Test System. Applicant as listed: Abaxis, Inc.. Decision date: 2021-10-20.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210511. Device: InTray GC. Applicant as listed: Biomed Diagnostics Incorporated. Decision date: 2021-10-20.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210873. Device: Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20. Applicant as listed: Oxoid Limited (Part of Thermo Fisher Scientific). Decision date: 2021-10-27.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200839. Device: APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module. Applicant as listed: Clever Culture Systems. Decision date: 2021-10-28.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K211199. Device: ST AIA-PACK BNP Assay. Applicant as listed: Tosoh Bioscience, Inc.. Decision date: 2021-11-08.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203184. Device: HYDRASHIFT 2/4 isatuximab. Applicant as listed: Sebia. Decision date: 2021-11-12.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210757. Device: ETEST Fosfomycin (FO) (0.032-512 µg/mL). Applicant as listed: Biomerieux S.A.. Decision date: 2021-11-12.
Source: api.fda.gov · Retrieved 2026-10-30
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.