PENTRA 80


Device Classification Name

counter, differential cell

510(k) Number K024002
Device Name PENTRA 80
Original Applicant
ABX DIAGNOSTICS
parc euromedecine
rue du caducee
monpellier, 

FR

34184

Original Contact tim lawton
Regulation Number 864.5220
Classification Product Code
GKZ  
Date Received 12/04/2002
Decision Date 01/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls