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 K232756. Device: Colibrí. Applicant as listed: Copan Wasp Srl. Decision date: 2023-12-27.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233790. Device: ACL TOP 970 CL. Applicant as listed: Instrumentation Laboratory. Decision date: 2023-12-29.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232597. Device: LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard). Applicant as listed: Hangzhou Laihe Biotech Co., Ltd.. Decision date: 2024-01-09.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232604. Device: LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette). Applicant as listed: Hangzhou Laihe Biotech Co., Ltd.. Decision date: 2024-01-10.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232732. Device: Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50. Applicant as listed: Co-Innovation Biotech Co., Ltd.. Decision date: 2024-01-17.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233242. Device: Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2024-01-18.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231237. Device: BD Vacutainer® Fluoride Blood Collection Tubes. Applicant as listed: Becton, Dickinson and Company. Decision date: 2024-01-19.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231187. Device: Nano-Check COVID-19 Antigen Test. Applicant as listed: Nano-Ditech Corporation. Decision date: 2024-01-23.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231290. Device: Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit. Applicant as listed: The Binding Site, Ltd.. Decision date: 2024-01-24.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231282. Device: LifeOutcomes C-Quest Blood Culture Sampling Device. Applicant as listed: Lifeoutcomes, LLC. Decision date: 2024-01-26.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232864. Device: EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II. Applicant as listed: Nantong Egens Biotechnology Co., Ltd.. Decision date: 2024-01-26.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231329. Device: Aptima Neisseria gonorrhoeae Assay. Applicant as listed: Hologic, Inc.. Decision date: 2024-01-26.
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.