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 K243776. Device: Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed). Applicant as listed: Zeus Scientific. Decision date: 2025-05-07.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242388. Device: LensHooke X12 PRO Semen Analysis System. Applicant as listed: Bonraybio Co., Ltd.. Decision date: 2025-05-09.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242294. Device: DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls. Applicant as listed: Diasys Diagnostic Systems GmbH. Decision date: 2025-05-09.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250377. Device: Flowflex Plus COVID-19 + Flu A/B Home Test. Applicant as listed: ACON Laboratories, Inc.. Decision date: 2025-05-10.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250414. Device: CaloPix. Applicant as listed: Tribun Health. Decision date: 2025-05-14.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250454. Device: HardyDisk Aztreonam/Avibactam 30/20µg (AZA50). Applicant as listed: Hardy Diagnostics. Decision date: 2025-05-15.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242585. Device: Cystatin C. Applicant as listed: SENTINEL CH. SpA. Decision date: 2025-05-16.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242706. Device: Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio. Applicant as listed: Fujirebio Diagnostics,Inc.. Decision date: 2025-05-16.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250447. Device: BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL). Applicant as listed: Becton, Dickinson and Company. Decision date: 2025-05-19.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242659. Device: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL. Applicant as listed: Thermo Fisher Scientific. Decision date: 2025-05-22.
Source: api.fda.gov · Retrieved 2026-10-24
FDA 510(k) K244047 — Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K244047. Device: Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG). Applicant as listed: Venocare, Inc.. Decision date: 2025-05-23.
Source: api.fda.gov · Retrieved 2026-10-24
FDA 510(k) K250549 — Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250549. Device: Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit. Applicant as listed: The Binding Site Group , Ltd.. Decision date: 2025-05-23.
Source: api.fda.gov · Retrieved 2026-10-19
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.