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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, All Groups, Streptococcus Spp.
510(k) Number K935667
Device Name QTEST(R) STREP
Applicant
Becton Dickinson Advanced Diagnostics
10 Loveton Circle
Sparks,  MD  21152
Applicant Contact JUDITH J SMITH
Correspondent
Becton Dickinson Advanced Diagnostics
10 Loveton Circle
Sparks,  MD  21152
Correspondent Contact JUDITH J SMITH
Regulation Number866.3740
Classification Product Code
GTY  
Date Received11/26/1993
Decision Date 04/21/1994
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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