BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS


Device Classification Name

system,test,thyroglobulin

510(k) Number K021057
Device Name BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS
Original Applicant
BRAHMS DIAGNOSTICA, LLC.
35 b south peachtree st.
norcross, 
GA 
30071

Original Contact william g frank
Regulation Number 866.6010
Classification Product Code
MSW  
Date Received 04/01/2002
Decision Date 09/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No