Cleared Traditional

ABBOTT PHENOBARBITAL ASSAY

K123271 · Microgenics Corp. · Chemistry
Apr 2013
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K123271 is an FDA 510(k) clearance for the ABBOTT PHENOBARBITAL ASSAY, a Enzyme Immunoassay, Phenobarbital (Class II — Special Controls, product code DLZ), submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on April 26, 2013, 189 days after receiving the submission on October 19, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3660.

Submission Details

510(k) Number K123271 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 2012
Decision Date April 26, 2013
Days to Decision 189 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DLZ — Enzyme Immunoassay, Phenobarbital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3660

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