POTENS +


Device Classification Name

system, multipurpose for in vitro coagulation studies

510(k) Number K033137
Device Name POTENS +
Applicant
WADA, INC.
35949 nicolet ct.
fremont, 
CA 
94536

Applicant Contact gail rodrick-highberg
Correspondent
WADA, INC.
35949 nicolet ct.
fremont, 
CA 
94536

Correspodent Contact gail rodrick-highberg
Regulation Number 864.5425
Classification Product Code
JPA  
Date Received 09/30/2003
Decision Date 12/08/2003
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