Source document or public record
FDA 510(k) K193649 — Yumizen C1200 Creatinine PAP
FDA 510(k) index record K193649. Device: Yumizen C1200 Creatinine PAP. Applicant as listed: HORIBA ABX SAS. Decision date: 2021-05-10.
Source
"device_name": "Yumizen C1200 Creatinine PAP"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K193649.
Device name: Yumizen C1200 Creatinine PAP. Applicant as listed: HORIBA ABX SAS.
Decision date: 2021-05-10. Decision wording: Substantially Equivalent.
Product code: JFY. Regulation: 21 CFR 862.1225. Medical specialty: Clinical Chemistry.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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