THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY— 510(k) K101754

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K101754 for THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY, Substantially Equivalent on 2011-04-08. Applicant: Microgenics Corp..

Clearance details

Applicant: Microgenics Corp.
Product code: Code DJG
Advisory panel: Clinical Toxicology
Date received: 2010-06-22
Decision date: 2011-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont Blvd., CA, US

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