BRAHMS DIAGNOSTICA LUMITEST ANTI-TG


information about

Device Classification Name

system, test, thyroid autoantibody

510(k) Number K000286
Device Name BRAHMS DIAGNOSTICA LUMITEST ANTI-TG
Original Applicant
BRAHMS DIAGNOSTICA, LLC.
29 south peachtree st.
norcross, 
GA 
30071

Original Contact h. lee herron
Regulation Number 866.5870
Classification Product Code
JZO  
Date Received 01/31/2000
Decision Date 03/17/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

Type Traditional
Reviewed by Third Party No

Combination Product

No