MULTIPLATE 5.0 AGGREGOMETER


Device Classification Name

system, automated platelet aggregation

510(k) Number K103555
Device Name MULTIPLATE 5.0 AGGREGOMETER
Applicant
VERUM DIAGNOSTICA GMBH
reichenbachstrasse 27
munich, 

DE

80469

Applicant Contact maximilian zucker
Correspondent
VERUM DIAGNOSTICA GMBH
reichenbachstrasse 27
munich, 

DE

80469

Correspodent Contact maximilian zucker
Regulation Number 864.5700
Classification Product Code
JOZ  
Date Received 12/03/2010
Decision Date 07/27/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No