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 K220677. Device: Kurin Blood Culture Collection Set with Kurin Lock Technology. Applicant as listed: Kurin, Inc.. Decision date: 2023-04-28.
Source: api.fda.gov · Retrieved 2026-10-28
FDA 510(k) K212743 — MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212743. Device: MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System. Applicant as listed: Medschenker, Inc.. Decision date: 2023-05-03.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230994. Device: Alinity i STAT High Sensitivity Troponin-I. Applicant as listed: Abbott Laboratories Diagnostics Division. Decision date: 2023-05-04.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203245. Device: Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C. Applicant as listed: Nucleix , Ltd.. Decision date: 2023-05-04.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213280. Device: BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App. Applicant as listed: Bd Kiestra B.V.. Decision date: 2023-05-04.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231017. Device: Panther Fusion AdV/hMPV/RV Assay. Applicant as listed: Hologic, Inc.. Decision date: 2023-05-05.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231081. Device: Dexcom G7 Continuous Glucose Monitoring (CGM) System. Applicant as listed: Dexcom, Inc.. Decision date: 2023-05-15.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230479. Device: ComASP Cefiderocol 0.008-128. Applicant as listed: Liofilchem s.r.l.. Decision date: 2023-05-18.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230790. Device: Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series. Applicant as listed: Abbott Laboratories. Decision date: 2023-05-19.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231137. Device: Xenta Drug Screen Cup, Xenta Drug Screen Dipcard. Applicant as listed: Xenta Biomedical Science Co., Ltd.. Decision date: 2023-05-19.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203599. Device: Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System. Applicant as listed: Immuno Concepts, N.A. , Ltd.. Decision date: 2023-05-26.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230408. Device: K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM). Applicant as listed: Sb-Kawasumi Laboratories, Inc.. Decision date: 2023-06-01.
Source: api.fda.gov · Retrieved 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.