FLOWCARE TLG REAGENT


Device Classification Name

counter, differential cell

510(k) Number K081526
Device Name FLOWCARE TLG REAGENT
Applicant
BECKMAN COULTER, INC.
11800 sw 147th ave.
m/s 31-b06
miami, 
FL 
33196 -2500

Applicant Contact nancy nadler
Correspondent
BECKMAN COULTER, INC.
11800 sw 147th ave.
m/s 31-b06
miami, 
FL 
33196 -2500

Correspodent Contact nancy nadler
Regulation Number 864.5220
Classification Product Code
GKZ  
Date Received 06/02/2008
Decision Date 08/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No

Combination Product

No