PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT


Device Classification Name

hexokinase, glucose

510(k) Number K103788
Device Name PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT
Applicant
HORIBA ABX SAS
parc euromedecine
rue du caducee – bp7290
montpellier, 

FR

34184

Applicant Contact caroline ferrer
Correspondent
HORIBA ABX SAS
parc euromedecine
rue du caducee – bp7290
montpellier, 

FR

34184

Correspodent Contact caroline ferrer
Regulation Number 862.1345
Classification Product Code
CFR  
Subsequent Product Codes
CEM   CGZ   JGS   JJE  
Date Received 12/27/2010
Decision Date 11/08/2011
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

Recalls CDRH Recalls