REDLINE ANTHRAX ALERT TEST


Device Classification Name

kit, immunochromatographic, bacillus anthracis differential antibody

510(k) Number K030370
Device Name REDLINE ANTHRAX ALERT TEST
Applicant
TETRACORE, INC
11 firstfield rd.
suite c
gaithersburg,, 
MD 
20878

Applicant Contact beverly l mangold
Correspondent
TETRACORE, INC
11 firstfield rd.
suite c
gaithersburg,, 
MD 
20878

Correspodent Contact beverly l mangold
Classification Product Code
NPO  
Date Received 02/04/2003
Decision Date 12/09/2003
Decision

substantially equivalent

(SESE)

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No