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 K200913. Device: Clearblue® Early Digital Pregnancy Test. Applicant as listed: Spd Swiss Precision Diagnostics GmbH. Decision date: 2021-08-13.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210958. Device: i-STAT CHEM8+ cartridge with the i-STAT 1 System. Applicant as listed: Abbott Point of Care, Inc.. Decision date: 2021-08-13.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210858. Device: VITROS Chemistry Products PHBR Slides. Applicant as listed: Ortho-Clinical Diagnostics, Inc.. Decision date: 2021-08-13.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203089. Device: Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System. Applicant as listed: Dexcom, Inc.. Decision date: 2021-08-17.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203227. Device: Elecsys HCG STAT. Applicant as listed: Roche Diagnostics. Decision date: 2021-08-18.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203790. Device: GEM Premier 5000. Applicant as listed: Instrumentation Laboratory CO. Decision date: 2021-08-20.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200230. Device: Aptiva Celiac Disease IgG Reagent. Applicant as listed: Inova Diagnostics, Inc.. Decision date: 2021-08-26.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K200748. Device: Visby Medical Sexual Health. Applicant as listed: Visby Medical. Decision date: 2021-08-26.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K210901. Device: Elecsys Vitamin D total III. Applicant as listed: Roche Diagnostics. Decision date: 2021-09-01.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201258. Device: EASYMAX Tag Self-Monitoring Blood Glucose System. Applicant as listed: Eps Bio Technology Corp.. Decision date: 2021-09-01.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202540. Device: EliA Rib-P. Applicant as listed: Phadia AB. Decision date: 2021-09-13.
Source: api.fda.gov · Retrieved 2026-10-30
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202541. Device: EliA RNA Pol III. Applicant as listed: Phadia AB. Decision date: 2021-09-13.
Source: api.fda.gov · Retrieved 2026-10-30
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.