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 K191030. Device: Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer. Applicant as listed: Life Technologies Corporation. Decision date: 2020-02-21.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192072. Device: Tina-quant C-Reactive Protein IV. Applicant as listed: Roche Diagnostics Operations (Rdo). Decision date: 2020-02-21.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200236. Device: VITROS BRAHMS PCT Reagent Pack and Calibrators. Applicant as listed: Ortho Clinical Diagnostics. Decision date: 2020-02-25.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200197. Device: ARK Fentanyl II Assay. Applicant as listed: Ark Diagnostics, Inc.. Decision date: 2020-02-26.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193313. Device: Elecsys Anti-TSHR. Applicant as listed: Roche Diagnostics. Decision date: 2020-02-27.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K191462. Device: Proov Test. Applicant as listed: Mfb Fertility, Inc.. Decision date: 2020-02-27.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193483. Device: Basal-IQ Technology. Applicant as listed: Tandem Diabetes Care, Inc.. Decision date: 2020-02-28.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192247. Device: Steripath Gen2 Blood Collection System. Applicant as listed: Magnolia Medical Technologies, Inc.. Decision date: 2020-02-28.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193532. Device: LIAISON Anti-HAV Assay. Applicant as listed: DiaSorin, Inc.. Decision date: 2020-03-02.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193358. Device: MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL). Applicant as listed: Beckman Coulter, Inc.. Decision date: 2020-03-03.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K191184. Device: ImmuView S pneumoniae and L pneumophila Urinary Antigen Test. Applicant as listed: Ssi Diagnostica A/S. Decision date: 2020-03-05.
Source: api.fda.gov · Retrieved 2026-10-19
FDA 510(k) index record K193393. Device: BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).. Applicant as listed: Leica Biosystems Newcastle, Ltd.. Decision date: 2020-03-06.
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.