Cleared Traditional

EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL

K130080 · Medica Corporation · Chemistry

May 2014

Decision

484d

Days

Class 2

Risk

About This 510(k) Submission

K130080 is an FDA 510(k) clearance for the EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL, a Colorimetric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHY), submitted by Medica Corporation (Bedford, US). The FDA issued a Cleared decision on May 13, 2014, 484 days after receiving the submission on January 14, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number	K130080 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 14, 2013
Decision Date	May 13, 2014
Days to Decision	484 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement