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 K251152. Device: DBLG2. Applicant as listed: Diabeloop. Decision date: 2025-12-19.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251074. Device: Tru Liver Health Test Panel. Applicant as listed: Truvian Health. Decision date: 2025-12-19.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253358. Device: Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay. Applicant as listed: Diazyme Laboratories, Inc.. Decision date: 2025-12-19.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253567. Device: Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card. Applicant as listed: Healgen Scientific,, LLC. Decision date: 2025-12-23.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251978. Device: LIAISON NES FLU A/B, RSV & COVID-19. Applicant as listed: Diasorin Molecular, LLC. Decision date: 2025-12-23.
Source: api.fda.gov · Retrieved 2026-10-22
FDA 510(k) index record K252493. Device: NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica). Applicant as listed: Hycor Biomedical. Decision date: 2025-12-23.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251800. Device: Healgen® URS Test Strips. Applicant as listed: Healgen Scientific,, LLC. Decision date: 2025-12-23.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251091. Device: Lipids. Applicant as listed: Truvian Health. Decision date: 2025-12-30.
Source: api.fda.gov · Retrieved 2026-10-22
FDA 510(k) index record K242492. Device: Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN). Applicant as listed: Techno-Path Manufacturing , Ltd.. Decision date: 2025-12-30.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K251630. Device: Atellica IM Total PSA II (tPSAII). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2026-01-05.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252749. Device: Medconn 8K Glycated Hemoglobin Test System. Applicant as listed: Shanghai Medconn Medical Technology Co., Ltd.. Decision date: 2026-01-06.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252206. Device: Nova Allegro UACR Assay, Nova Allegro Analyzer. Applicant as listed: Nova Biomedical Corporation. Decision date: 2026-01-09.
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.