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 K230827. Device: HardyDisk AST Rezafungin 5µg (RZF5). Applicant as listed: Hardy Diagnostics. Decision date: 2023-06-01.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220728. Device: vWF Ag. Applicant as listed: Siemens Healthcare Diagnostics Products GmbH. Decision date: 2023-06-02.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221801. Device: ADVIA Centaur® Anti-Müllerian Hormone (AMH). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2023-06-02.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231348. Device: Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF. Applicant as listed: Roche Diagnostics. Decision date: 2023-06-05.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230937. Device: Alinity i Total ß-hCG Reagent Kit, GLP systems Track. Applicant as listed: Abbott Laboratories. Decision date: 2023-06-05.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213611. Device: Fenom Pro. Applicant as listed: Caire Diagnostics, Inc.. Decision date: 2023-06-07.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212183. Device: STA R Max 3, STA Compact Max 3. Applicant as listed: Diagnostica Stago S.A.S. Decision date: 2023-06-07.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230651. Device: BD BBL Sensi-Disc Lefamulin 20µg (LMU-20). Applicant as listed: Becton, Dickinson and Company. Decision date: 2023-06-07.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223078. Device: Atellica® CH Diazo Direct Bilirubin (D_DBil). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2023-06-12.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231469. Device: PAXgene® Blood DNA Tube. Applicant as listed: Preanalytix GmbH. Decision date: 2023-06-21.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231031. Device: ACL TOP Family 70 Series. Applicant as listed: Instrumentation Laboratory Company. Decision date: 2023-06-21.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223187. Device: HemosIL Liquid Anti-Xa. Applicant as listed: Instrumentation Laboratory CO. Decision date: 2023-06-23.
Fuente: api.fda.gov · Consultado el 2026-10-28
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.