ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT


Device Classification Name

assay, glycosylated hemoglobin

510(k) Number K073309
Device Name ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT
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 864.7470
Classification Product Code
LCP  
Subsequent Product Codes
JIX   JJY  
Date Received 11/23/2007
Decision Date 10/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No