HDL CHOLESTEROL REAGENT, MODEL 10211


Device Classification Name

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

510(k) Number K073497
Device Name HDL CHOLESTEROL REAGENT, MODEL 10211
Applicant
MEDICA CORP.
5 oak park drive
bedford, 
MA 
01730

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

Correspodent Contact photios makris
Regulation Number 862.1475
Classification Product Code
LBS  
Subsequent Product Code
JIT  
Date Received 12/13/2007
Decision Date 04/14/2008
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