Documento fuente o registro público
FDA 510(k) K192730 — CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV
FDA 510(k) index record K192730. Device: CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV. Applicant as listed: Biosystems S.A.. Decision date: 2020-09-09.
Fuente
"device_name": "CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K192730.
Device name: CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV. Applicant as listed: Biosystems S.A..
Decision date: 2020-09-09. Decision wording: Substantially Equivalent.
Product code: CHW. Regulation: 21 CFR 862.1145. 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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