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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 K904496
Device Name CROMATEST SYPHILIS DIAGNOSTIC
Applicant
Biotrax, Inc.
5202 Westland Blvd.
Baltimore,  MD  21227
Applicant Contact SANTO GRILLO
Correspondent
Biotrax, Inc.
5202 Westland Blvd.
Baltimore,  MD  21227
Correspondent Contact SANTO GRILLO
Regulation Number866.3820
Classification Product Code
GMQ  
Date Received10/02/1990
Decision Date 07/24/1991
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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