CEDIA Heroin Metabolite (6-AM) Assay— 510(k) K231007

Name: FDA 510(k) clearance K231007
Creator: U.S. Food and Drug Administration
Published: 2023-09-27

Substantially Equivalent

Microgenics Corporation

FDA 510(k) clearance K231007 for CEDIA Heroin Metabolite (6-AM) Assay, Substantially Equivalent on 2023-09-27. Applicant: Microgenics Corporation. Device class: 2.

Clearance details

Applicant: Microgenics Corporation
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2023-04-07
Decision date: 2023-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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