CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY


Device Classification Name

counter, differential cell

510(k) Number K010953
Device Name CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
Original Applicant
ABBOTT LABORATORIES
5440 patrick henry dr.
santa clara, 
CA 
95054

Original Contact john dean
Regulation Number 864.5220
Classification Product Code
GKZ  
Date Received 03/30/2001
Decision Date 06/06/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls