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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact BEVERLY L MANGOLD
Regulation Number866.3045
Classification Product Code
NPO  
Date Received02/04/2003
Decision Date 12/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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