Source document or public record
FDA 510(k) K192517 — Psychemedics Microplate EIA for Cotinine in Hair
FDA 510(k) index record K192517. Device: Psychemedics Microplate EIA for Cotinine in Hair. Applicant as listed: Psychemedics Corporation. Decision date: 2020-04-22.
Source
"device_name": "Psychemedics Microplate EIA for Cotinine 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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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K192517.
Device name: Psychemedics Microplate EIA for Cotinine in Hair. Applicant as listed: Psychemedics Corporation.
Decision date: 2020-04-22. Decision wording: Substantially Equivalent.
Product code: MKU. Regulation: 21 CFR 862.3220. 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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