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 K230956. Device: BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System. Applicant as listed: Bd Integrated Diagnostic Solutions /. Decision date: 2023-07-31.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221114. Device: Immunoglobulin G (IgG). Applicant as listed: Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.. Decision date: 2023-08-02.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222635. Device: Premier Resolution System. Applicant as listed: Trinity Biotech (Primus Corporation, Dba Trinity Biotech). Decision date: 2023-08-04.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220828. Device: SQA-iO Sperm Quality Analyzer. Applicant as listed: Medical Electronic Systems , Ltd.. Decision date: 2023-08-07.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222439. Device: Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2023-08-08.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231525. Device: VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack. Applicant as listed: Ortho Clinical Diagnostics. Decision date: 2023-08-09.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223608. Device: GEM Premier 7000 with IQM3. Applicant as listed: Instrumentation Laboratory Company. Decision date: 2023-08-10.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230625. Device: ReliOn Premier BLU Blood Glucose Monitoring System. Applicant as listed: I-Sens, Inc.. Decision date: 2023-08-10.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213131. Device: Accu-Chek Guide Solo diabetes manager blood glucose monitoring system. Applicant as listed: Roche Diabetes Care GmbH. Decision date: 2023-08-10.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221925. Device: ID NOW COVID-19 2.0. Applicant as listed: Abbott Diagnostics Scarborough, Inc.. Decision date: 2023-08-10.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222850. Device: HAVAb IgG II. Applicant as listed: Abbott Laboratories. Decision date: 2023-08-10.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222888. Device: BlueStar CGM insulin dose calculator. Applicant as listed: Welldoc, Inc.. Decision date: 2023-08-11.
Source: api.fda.gov · Retrieved 2026-10-27
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.