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 K201902. Device: MammaPrint. Applicant as listed: Agendia, Inc.. Decision date: 2020-11-05.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200811. Device: cobas u 701 microscopy analyzer. Applicant as listed: Roche Diagnostics. Decision date: 2020-11-06.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201269. Device: Accula Strep A Test. Applicant as listed: Mesa Biotech, Inc.. Decision date: 2020-11-09.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202343. Device: MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL ). Applicant as listed: Beckman Coulter, Inc.. Decision date: 2020-11-16.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202382. Device: FilmArray Global Fever Panel External Control Kit. Applicant as listed: Biofire Defense, LLC. Decision date: 2020-11-20.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193508. Device: Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20. Applicant as listed: Oxoid Limited (Part of Thermo Fisher Scientific). Decision date: 2020-12-04.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200876. Device: Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System. Applicant as listed: Dexcom, Inc.. Decision date: 2020-12-04.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192916. Device: NOVA Lite DAPI dsDNA Crithidia luciliae Kit. Applicant as listed: Inova Diagnostics, Inc.. Decision date: 2020-12-11.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202641. Device: DNA/RNA Shield Collection Tube. Applicant as listed: Zymo Research. Decision date: 2020-12-14.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192073. Device: Helix Genetic Health Risk App for late-onset Alzheimers disease. Applicant as listed: Helix Opco, LLC. Decision date: 2020-12-23.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193419. Device: MBT Sepsityper. Applicant as listed: Bruker Daltonik GmbH. Decision date: 2020-12-27.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201778. Device: i-STAT TBI Plasma cartridge with the i-STAT Alinity System. Applicant as listed: Abbott Laboratories. Decision date: 2021-01-08.
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.