COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526


Device Classification Name

counter, differential cell

510(k) Number K010765
Device Name COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526
Original Applicant
BECKMAN COULTER, INC.
11800 s.w. 14th ave.
p.o.box 169015
miami, 
FL 
33116 -9015

Original Contact stan sugrue
Regulation Number 864.5220
Classification Product Code
GKZ  
Date Received 03/14/2001
Decision Date 04/13/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls