Documento fuente o registro público
FDA 510(k) K213211 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
FDA 510(k) index record K213211. Device: Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System. Applicant as listed: Carolina Liquid Chemistries Corp.. Decision date: 2022-01-27.
Fuente
"device_name": "Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System"
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
2026-10-31
professional use
FDA 510(k) public index record K213211.
Device name: Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System. Applicant as listed: Carolina Liquid Chemistries Corp..
Decision date: 2022-01-27. Decision wording: Substantially Equivalent.
Product code: DIO. Regulation: 21 CFR 862.3250. Medical specialty: Clinical Toxicology.
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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