CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A


Device Classification Name

counter, differential cell

510(k) Number K030408
Device Name CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A
Applicant
BECKMAN COULTER, INC.
11800 sw 147th ave.
m/s 31-b06
miami, 
FL 
33196 -2500

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

Correspodent Contact stan sugrue
Regulation Number 864.5220
Classification Product Code
GKZ  
Date Received 02/07/2003
Decision Date 03/04/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls