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FDA 510(k) K210212 — Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair
FDA 510(k) index record K210212. Device: Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair. Applicant as listed: Psychemedics Corporation. Decision date: 2021-12-15.
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"device_name": "Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair"
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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2026-10-20
2026-10-20
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FDA 510(k) public index record K210212.
Device name: Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair. Applicant as listed: Psychemedics Corporation.
Decision date: 2021-12-15. Decision wording: Substantially Equivalent.
Product code: LAF. Regulation: 21 CFR 862.3610. 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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