COULTER Z2 ANALYZER


Device Classification Name

counter, cell, automated (particle counter)

510(k) Number K991070
Device Name COULTER Z2 ANALYZER
Applicant
COULTER CORP.
1950 west 8th ave.
hialeah, 
FL 
33010

Applicant Contact thomas j english
Correspondent
COULTER CORP.
1950 west 8th ave.
hialeah, 
FL 
33010

Correspodent Contact thomas j english
Regulation Number 864.5200
Classification Product Code
GKL  
Date Received 03/31/1999
Decision Date 05/11/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No