CEDIA VANCOMYCIN ASSAY— 510(k) K032811

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K032811 for CEDIA VANCOMYCIN ASSAY, Substantially Equivalent on 2003-11-24. Applicant: Microgenics Corp..

Clearance details

Applicant: Microgenics Corp.
Product code: Code LEH
Advisory panel: Clinical Toxicology
Date received: 2003-09-09
Decision date: 2003-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont Blvd., CA, US

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