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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FDA 510(k) index record K233624. Device: HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx. Applicant as listed: Hangzhou Aichek Medical Technology Co., Ltd.. Decision date: 2024-04-12.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232904. Device: Access Ostase. Applicant as listed: Beckman Coulter. Decision date: 2024-04-15.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232208. Device: Sectra Digital Pathology Module (Version 3.3). Applicant as listed: Sectra AB. Decision date: 2024-04-16.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232202. Device: Aperio GT 450 DX. Applicant as listed: Leica Biosystems Imaging, Inc.. Decision date: 2024-04-16.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232377. Device: Healgen Rapid COVID-19 Antigen Test. Applicant as listed: Healgen Scientific,, LLC. Decision date: 2024-04-19.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233373. Device: Flowflex® Plus COVID-19 Home Test. Applicant as listed: ACON Laboratories, Inc.. Decision date: 2024-04-19.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240182. Device: Access EPO. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2024-04-22.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233537. Device: FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System. Applicant as listed: Abbott Diabetes Care, Inc.. Decision date: 2024-04-23.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240902. Device: Dexcom G7 Continuous Glucose Monitoring System. Applicant as listed: Dexcom, Inc.. Decision date: 2024-04-23.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232357. Device: Copan Universal Transport Medium (UTM-RT) System. Applicant as listed: Copan Italia Spa. Decision date: 2024-04-25.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221688. Device: ASTar BC G- Kit and ASTar Instrument. Applicant as listed: Q-Linea AB. Decision date: 2024-04-26.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232317. Device: UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips. Applicant as listed: Urit Medical Electronic Co., Ltd.. Decision date: 2024-04-26.
Source: api.fda.gov · Retrieved 2026-10-26
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.