SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500


Device Classification Name

instrument, coagulation, automated

510(k) Number K992423
Device Name SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500
Applicant
DADE BEHRING, INC.
1851 delaware pkwy.
miami, 
FL 
33125

Applicant Contact radames riesgo
Correspondent
DADE BEHRING, INC.
1851 delaware pkwy.
miami, 
FL 
33125

Correspodent Contact radames riesgo
Regulation Number 864.5400
Classification Product Code
GKP  
Subsequent Product Code
JPA  
Date Received 07/21/1999
Decision Date 09/21/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized