EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT


Device Classification Name

enzymatic esterase–oxidase, cholesterol

510(k) Number K072249
Device Name EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT
Applicant
MEDICA CORP.
163 cabot street
beverly, 
MA 
01915

Applicant Contact fran white
Correspondent
MEDICA CORP.
163 cabot street
beverly, 
MA 
01915

Correspodent Contact fran white
Regulation Number 862.1175
Classification Product Code
CHH  
Subsequent Product Code
CJY  
Date Received 08/13/2007
Decision Date 02/20/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No