Cleared Traditional

CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set

K163101 · Microgenics Corporation · Toxicology
Apr 2017
Decision
150d
Days
Class 2
Risk

About This 510(k) Submission

K163101 is an FDA 510(k) clearance for the CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Microgenics Corporation (Fremond, US). The FDA issued a Cleared decision on April 6, 2017, 150 days after receiving the submission on November 7, 2016. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K163101 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2016
Decision Date April 06, 2017
Days to Decision 150 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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