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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Nontreponemal, All
510(k) Number K000687
Device Name THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST
Applicant
Beacon Biologicals, Inc.
6004 Glendale Dr.
Boca Raton,  FL  33433
Applicant Contact KANTI DAYA
Correspondent
Beacon Biologicals, Inc.
6004 Glendale Dr.
Boca Raton,  FL  33433
Correspondent Contact KANTI DAYA
Regulation Number866.3820
Classification Product Code
GMQ  
Date Received02/29/2000
Decision Date 06/12/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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