CHOLESTRAK HDL CHOLESTEROL HOME TEST


Device Classification Name

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

510(k) Number K072836
Device Name CHOLESTRAK HDL CHOLESTEROL HOME TEST
Applicant
ACCUTECH, LLC.
150 cherry lane road
east stroudsburg, 
PA 
18301

Applicant Contact gary lehnus
Correspondent
ACCUTECH, LLC.
150 cherry lane road
east stroudsburg, 
PA 
18301

Correspodent Contact gary lehnus
Regulation Number 862.1475
Classification Product Code
LBS  
Subsequent Product Code
NAQ  
Date Received 10/03/2007
Decision Date 12/27/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No