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.
Filter documents
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240025. Device: Clearblue® Early Detection Pregnancy Test. Applicant as listed: Spd Swiss Precision Diagnostics GmbH. Decision date: 2024-01-31.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231373. Device: BD Vacutainer® K2 EDTA Blood Collection Tubes. Applicant as listed: Becton, Dickinson and Company. Decision date: 2024-02-02.
Source: api.fda.gov · Retrieved 2026-10-19
FDA 510(k) K233174 — FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233174. Device: FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream. Applicant as listed: Assure Tech. (Hangzhou) Co, Ltd.. Decision date: 2024-02-05.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232057. Device: BÜHLMANN fCAL® turbo and CALEX® Cap. Applicant as listed: Bühlmann Laboratories AG. Decision date: 2024-02-06.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233184. Device: T2Bacteria® Panel. Applicant as listed: T2biosystems, Inc.. Decision date: 2024-02-08.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233480. Device: Access SHBG. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2024-02-08.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231536. Device: eQUANT System. Applicant as listed: Avails Medical, Inc.. Decision date: 2024-02-08.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230839. Device: Concentriq Dx. Applicant as listed: Proscia, Inc.. Decision date: 2024-02-08.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K234005. Device: Access CK-MB. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2024-02-16.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233775. Device: Vivatmo pro. Applicant as listed: Bosch Healthcare Solutions GmbH. Decision date: 2024-02-22.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231679. Device: CONTOUR® PLUS BLUE Blood Glucose Monitoring System. Applicant as listed: Ascensia Diabetes Care. Decision date: 2024-02-23.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232228. Device: Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card. Applicant as listed: Shanghai Accurature Diagnostics Co., Ltd.. Decision date: 2024-02-23.
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.