CARDIOIMMUNE XL CARDIAC MARKER CONTROL— 510(k) K061196

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K061196 for CARDIOIMMUNE XL CARDIAC MARKER CONTROL, Substantially Equivalent on 2006-05-30. Applicant: Microgenics Corp..

Clearance details

Applicant: Microgenics Corp.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 2006-04-28
Decision date: 2006-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont Blvd., CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.