K123586

Substantially Equivalent

EASYRA CREATININE REAGENT

Applicant: Medica Corporation
Product code: CGX
Advisory panel: Clinical Chemistry
Date received: 2012-11-21
Decision date: 2013-05-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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