EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT


Device Classification Name

ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl

510(k) Number K111036
Device Name EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT
Applicant
MEDICA CORPORATION
5 oak park drive
bedford, 
MA 
01730

Applicant Contact photios makris
Correspondent
MEDICA CORPORATION
5 oak park drive
bedford, 
MA 
01730

Correspodent Contact photios makris
Regulation Number 862.1475
Classification Product Code
LBS  
Subsequent Product Codes
CDT   CHH   MRR  
Date Received 04/14/2011
Decision Date 07/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No