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 K252932. Device: Fast PCR Mini Respiratory Panel. Applicant as listed: Autonomous Medical Devices Incorporated. Decision date: 2026-06-12.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252323. Device: cobas pulse blood glucose monitoring system. Applicant as listed: Roche Diagnostics. Decision date: 2026-06-12.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260333. Device: LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit. Applicant as listed: Diasorin Molecular, LLC. Decision date: 2026-06-15.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253069. Device: Lipoprotein (a) Molarity Assay. Applicant as listed: Diazyme Laboratories, Inc.. Decision date: 2026-06-16.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K261099. Device: Blood Volume Analyzer (200). Applicant as listed: Daxor Corporation. Decision date: 2026-06-18.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260280. Device: NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg. Applicant as listed: Hycor Biomedical. Decision date: 2026-06-18.
Source: api.fda.gov · Retrieved 2026-10-20
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253367. Device: EliA CTD 13 Screen. Applicant as listed: Phadia AB. Decision date: 2026-06-25.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253316. Device: PhAST instrument and PhAST Blood Culture Gram-negative Panel. Applicant as listed: Phast Corp.. Decision date: 2026-06-26.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K261039. Device: i-STAT Crea cartridge with the i-STAT 1 System. Applicant as listed: Abbott Point of Care, Inc.. Decision date: 2026-06-26.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K261461. Device: Omnipod 6 algorithm. Applicant as listed: Insulet Corporation. Decision date: 2026-06-29.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K261867. Device: Xpert Carba-R. Applicant as listed: Cepheid®. Decision date: 2026-07-02.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252243. Device: Fastplex BCR-ABL (p210) %IS digital PCR Kit. Applicant as listed: Suzhou Precigenome, Ltd. Co;. Decision date: 2026-07-02.
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.