Documento fuente o registro público
FDA 510(k) K190968 — CEDIA Benzodiazepine Assay
FDA 510(k) index record K190968. Device: CEDIA Benzodiazepine Assay. Applicant as listed: Microgenics Corporation. Decision date: 2019-12-09.
Fuente
"device_name": "CEDIA Benzodiazepine Assay"
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Review and references
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2026-10-20
2026-10-20
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FDA 510(k) public index record K190968.
Device name: CEDIA Benzodiazepine Assay. Applicant as listed: Microgenics Corporation.
Decision date: 2019-12-09. Decision wording: Substantially Equivalent.
Product code: JXM. Regulation: 21 CFR 862.3170. 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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