MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE


Device Classification Name

counter, differential cell

510(k) Number K960531
Device Name MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE
Applicant
DAKO CORP.
6392 via real
carpinteria, 
CA 
93013

Applicant Contact gretchen m murray
Correspondent
DAKO CORP.
6392 via real
carpinteria, 
CA 
93013

Correspodent Contact gretchen m murray
Regulation Number 864.5220
Classification Product Code
GKZ  
Date Received 02/07/1996
Decision Date 06/14/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No