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 K213379. Device: Clearblue ® Early Pregnancy Test. Applicant as listed: Spd Swiss Precision Diagnostics GmbH. Decision date: 2022-09-21.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K201237. Device: Velano Vascular Blood Collection Adapter. Applicant as listed: Velano Vascular. Decision date: 2022-10-03.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220546. Device: Colibrí System. Applicant as listed: Copan Wasp Srl. Decision date: 2022-10-05.
Source: api.fda.gov · Retrieved 2026-10-29
FDA 510(k) K212779 — Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212779. Device: Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing. Applicant as listed: Coagusense, Inc.. Decision date: 2022-10-05.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213061. Device: SuperCheck Pro Blood Glucose Monitoring System. Applicant as listed: Ok Biotech Co., Ltd.. Decision date: 2022-10-07.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220924. Device: Elecsys HSV-2 IgG (08948887160). Applicant as listed: Roche Diagnostics. Decision date: 2022-10-12.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220923. Device: Elecsys HSV-1 IgG (08948844160). Applicant as listed: Roche Diagnostics. Decision date: 2022-10-12.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220911. Device: Elecsys CMV IgG. Applicant as listed: Roche Diagnostics. Decision date: 2022-10-12.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220805. Device: VITEK 2 AST-Gram Positive Cefoxitin Screen. Applicant as listed: bioMerieux, Inc.. Decision date: 2022-10-13.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213396. Device: SPIFE A1AT kit. Applicant as listed: Helena Laboratories, Corp.. Decision date: 2022-10-13.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203549. Device: Nova Primary Glucose Analyzer System. Applicant as listed: Nova Biomedical Corporation. Decision date: 2022-10-18.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220870. Device: BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel. Applicant as listed: Biofire Defense, LLC. Decision date: 2022-10-20.
Source: api.fda.gov · Retrieved 2026-10-29
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.