DIMERTEST


Device Classification Name

fibrinogen and fibrin split products, antigen, antiserum, control

510(k) Number K080069
Device Name DIMERTEST
Applicant
AMERICAN DIAGNOSTICA, INC.
500 west avenue
stamford, 
CT 
06902

Applicant Contact leigh ayres
Correspondent
AMERICAN DIAGNOSTICA, INC.
500 west avenue
stamford, 
CT 
06902

Correspodent Contact leigh ayres
Regulation Number 864.7320
Classification Product Code
DAP  
Date Received 01/10/2008
Decision Date 02/13/2008
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