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 K253957. Device: HemosIL Silica Clotting Time. Applicant as listed: Instrumentation Laboratory (IL) Co.. Decision date: 2026-01-09.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251157. Device: Core Metabolic. Applicant as listed: Truvian Health. Decision date: 2026-01-09.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253585. Device: SmartGuard technology; Predictive Low Glucose technology. Applicant as listed: Medtronic Minimed, Inc.. Decision date: 2026-01-14.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252283. Device: Nano-Check Influenza A+B Test. Applicant as listed: Nano-Ditech Corporation. Decision date: 2026-01-15.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251249. Device: Tru Hematology Test. Applicant as listed: Truvian Sciences, Inc.. Decision date: 2026-01-16.
Source: api.fda.gov · Retrieved 2026-10-22
FDA 510(k) index record K252775. Device: NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg. Applicant as listed: Hycor Biomedical. Decision date: 2026-01-16.
Source: api.fda.gov · Retrieved 2026-10-20
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253082. Device: LZI Buprenorphine II Enzyme Immunoassay. Applicant as listed: Lin-Zhi International, Inc.. Decision date: 2026-01-16.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251721. Device: Xpert GI Panel. Applicant as listed: Cepheid. Decision date: 2026-01-16.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251281. Device: Nova Max Creat eGFR Monitoring System. Applicant as listed: Nova Biomedical Corporation. Decision date: 2026-01-21.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251511. Device: PhenoMATRIX. Applicant as listed: Copan Wasp Srl. Decision date: 2026-01-22.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K250741. Device: Evidence MultiSTAT DOA Urine MultiPlex. Applicant as listed: Randox Laboratories Limited. Decision date: 2026-01-23.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251995. Device: Access anti-HAV IgM. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2026-01-27.
Source: api.fda.gov · Retrieved 2026-10-22
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.