MODIFICATION TO PENTRA 60 AND PENTRA 60C+


Device Classification Name

counter, differential cell

510(k) Number K030144
Device Name MODIFICATION TO PENTRA 60 AND PENTRA 60C+
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 01/15/2003
Decision Date 01/31/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No