Source document or public record
FDA 510(k) K231007 — CEDIA Heroin Metabolite (6-AM) Assay
FDA 510(k) index record K231007. Device: CEDIA Heroin Metabolite (6-AM) Assay. Applicant as listed: Microgenics Corporation. Decision date: 2023-09-27.
Source
"device_name": "CEDIA Heroin Metabolite (6-AM) Assay"
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 K231007.
Device name: CEDIA Heroin Metabolite (6-AM) Assay. Applicant as listed: Microgenics Corporation.
Decision date: 2023-09-27. Decision wording: Substantially Equivalent.
Product code: DJG. Regulation: 21 CFR 862.3650. 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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