ABBOTT PHENOBARBITAL ASSAY— 510(k) K123271

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K123271 for ABBOTT PHENOBARBITAL ASSAY, Substantially Equivalent on 2013-04-26. Applicant: Microgenics Corp.. Device class: 2.

Clearance details

Applicant: Microgenics Corp.
Product code: Code DLZ
Device class: Class 2
Regulation: 21 CFR 862.3660
Advisory panel: Clinical Toxicology
Date received: 2012-10-19
Decision date: 2013-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont Blvd., CA, US

Download summary PDF View on FDA.gov ↗

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