MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632


Device Classification Name

counter, differential cell

510(k) Number K022161
Device Name MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
Original Applicant
BECKMAN COULTER, INC.
11800 sw 147th ave.
m/s 31-b06
miami, 
FL 
33196 -2500

Original Contact stan sugrue
Regulation Number 864.5220
Classification Product Code
GKZ  
Date Received 07/03/2002
Decision Date 07/29/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No