APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201


Device Classification Name

hexokinase, glucose

510(k) Number K080123
Device Name APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 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 862.1345
Classification Product Code
CFR  
Subsequent Product Code
LCP  
Date Received 01/17/2008
Decision Date 07/17/2008
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