ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN


Device Classification Name

enzymatic method, creatinine

510(k) Number K110137
Device Name ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN
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
JFY  
Subsequent Product Codes
JIX   JJY  
Date Received 01/18/2011
Decision Date 08/10/2011
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