Documento fuente o registro público
FDA 510(k) K201228 — Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair
FDA 510(k) index record K201228. Device: Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair. Applicant as listed: Psychemedics Corporation. Decision date: 2021-06-25.
Fuente
"device_name": "Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair"
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Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K201228.
Device name: Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair. Applicant as listed: Psychemedics Corporation.
Decision date: 2021-06-25. Decision wording: Substantially Equivalent.
Product code: JXO. 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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