ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER


Device Classification Name

counter, differential cell

510(k) Number K991839
Device Name ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER
Applicant
ABX DIAGNOSTICS
7777 center ave.
suite 102
huntington beach, 
CA 
92647

Applicant Contact pat amtower
Correspondent
ABX DIAGNOSTICS
7777 center ave.
suite 102
huntington beach, 
CA 
92647

Correspodent Contact pat amtower
Regulation Number 864.5220
Classification Product Code
GKZ  
Date Received 05/28/1999
Decision Date 08/11/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No