ABACUS 3CP


Device Classification Name

counter, differential cell

510(k) Number K111534
Device Name ABACUS 3CP
Applicant
DIATRON US INC
14026 w. 107th street
lenexa, 
KS 
66215 -2005

Applicant Contact michael switzer
Correspondent
DIATRON US INC
14026 w. 107th street
lenexa, 
KS 
66215 -2005

Correspodent Contact michael switzer
Regulation Number 864.5220
Classification Product Code
GKZ  
Date Received 06/02/2011
Decision Date 08/02/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No