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 K260964. Device: NanoZoomer S540MD Slide Scanner System. Applicant as listed: Hamamatsu Photonics K.K.. Decision date: 2026-07-22.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K261853. Device: Gepotidacin GEP 10 µg. Applicant as listed: Liofilchem, Inc.. Decision date: 2026-07-23.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K262116. Device: TRUE METRIX Self Monitoring Blood Glucose System. Applicant as listed: Trividia Health, Inc.. Decision date: 2026-07-23.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K261364. Device: Atellica CH Acetaminophen 2 (ACTM). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2026-07-24.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K261781. Device: Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60. Applicant as listed: Thermo Fisher Scientific (Oxoid Ltd.). Decision date: 2026-07-24.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K261027. Device: NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut. Applicant as listed: Hycor Biomedical. Decision date: 2026-07-24.
Source: api.fda.gov · Retrieved 2026-10-20
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K261380. Device: Concentriq AP-Dx. Applicant as listed: Proscia, Inc.. Decision date: 2026-08-05.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K254194. Device: QIAstat-Dx BCID GPF Plus AMR Panel. Applicant as listed: QIAGEN GmbH. Decision date: 2026-08-06.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253453. Device: Metrix COVID Test; Metrix COVID Test Pro. Applicant as listed: Aptitude Medical Systems, Inc.. Decision date: 2026-08-07.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253561. Device: Aperio iQC DX Software. Applicant as listed: Leica Biosystems Imaging, Inc.. Decision date: 2026-08-07.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K261362. Device: Xpert Hemorrhagic Fever. Applicant as listed: Cepheid. Decision date: 2026-08-07.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253554. Device: Aperio GT 450 DX; Aperio GT 180 DX. Applicant as listed: Leica Biosystems Imaging, Inc.. Decision date: 2026-08-07.
Source: api.fda.gov · Retrieved 2026-10-21
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.