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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antistreptolysin - Titer/Streptolysin O Reagent
510(k) Number K904416
Device Name CROATEST (R) RHEUMATOID DIAGNOSTIC
Applicant
Biotrax, Inc.
5202 Westland Blvd.
Baltimore,  MD  21227
Applicant Contact SANTO L GRILLO
Correspondent
Biotrax, Inc.
5202 Westland Blvd.
Baltimore,  MD  21227
Correspondent Contact SANTO L GRILLO
Regulation Number866.3720
Classification Product Code
GTQ  
Date Received09/27/1990
Decision Date 06/24/1991
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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