ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H


Device Classification Name

hexokinase, glucose

510(k) Number K081276
Device Name ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H
Applicant
HORIBA ABX
parc euromedecine
rue du caducee, bp 7290
montpellier, 

FR

34184

Applicant Contact olivier ducamp
Correspondent
HORIBA ABX
parc euromedecine
rue du caducee, bp 7290
montpellier, 

FR

34184

Correspodent Contact olivier ducamp
Regulation Number 862.1345
Classification Product Code
CFR  
Subsequent Product Codes
JJY   KNK  
Date Received 05/05/2008
Decision Date 09/12/2008
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