TETRACHROME REAGENTS AND TETRACXP SYSTEM


Device Classification Name

flow cytometric reagents and accessories.

510(k) Number K121445
Device Name TETRACHROME REAGENTS AND TETRACXP SYSTEM
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
OYE  
Date Received 05/15/2012
Decision Date 07/26/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No