ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL


Device Classification Name

alkaline picrate, colorimetry, creatinine

510(k) Number K110530
Device Name ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL
Applicant
HORIBA ABX S.A.S.
parc euromedecine
rue du caducee-bp 7290
montpellier cedex 4, herault, 

FR

34184

Applicant Contact caroline ferrer
Correspondent
HORIBA ABX S.A.S.
parc euromedecine
rue du caducee-bp 7290
montpellier cedex 4, herault, 

FR

34184

Correspodent Contact caroline ferrer
Regulation Number 862.1225
Classification Product Code
CGX  
Subsequent Product Codes
JIX   JJY  
Date Received 02/24/2011
Decision Date 04/30/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls