Source document or public record
FDA 510(k) K191638 — Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
FDA 510(k) index record K191638. Device: Pointe Scientific Cocaine Metabolite Enzyme Immunoassay. Applicant as listed: Medtest DX. Decision date: 2020-03-12.
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"device_name": "Pointe Scientific Cocaine Metabolite Enzyme Immunoassay"
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 K191638.
Device name: Pointe Scientific Cocaine Metabolite Enzyme Immunoassay. Applicant as listed: Medtest DX.
Decision date: 2020-03-12. 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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