Cleared Traditional

CEDIA BUPRENORPHINE ASSAY

K040316 · Microgenics Corp. · Toxicology
Jun 2004
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K040316 is an FDA 510(k) clearance for the CEDIA BUPRENORPHINE ASSAY, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on June 23, 2004, 135 days after receiving the submission on February 9, 2004. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K040316 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2004
Decision Date June 23, 2004
Days to Decision 135 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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