K130628

Substantially Equivalent

PATHFAST CK-MB-II CALIBRATORS

Applicant: Mitsubishi Chemical Medience Corporation
Product code: JIT
Advisory panel: Clinical Chemistry
Date received: 2013-03-08
Decision date: 2013-10-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Bethesda, MD, US

Download summary PDF View on FDA.gov ↗

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