CEDIA DAU AMPHASSURE ASSAY— 510(k) K994380

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K994380 for CEDIA DAU AMPHASSURE ASSAY, Substantially Equivalent on 2000-05-02. Applicant: Microgenics Corp..

Clearance details

Applicant: Microgenics Corp.
Product code: Code DKZ
Advisory panel: Clinical Toxicology
Date received: 1999-12-27
Decision date: 2000-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont Blvd., CA, US

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