APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201


Device Classification Name

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

510(k) Number K080125
Device Name APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201
Applicant
WAKO CHEMICALS USA, INC.
1600 bellwood road
richmond, 
VA 
23237

Applicant Contact peter panfili
Correspondent
WAKO CHEMICALS USA, INC.
1600 bellwood road
richmond, 
VA 
23237

Correspodent Contact peter panfili
Regulation Number 862.1475
Classification Product Code
LBS  
Subsequent Product Codes
CDT   CGO   JJE  
Date Received 01/17/2008
Decision Date 07/18/2008
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