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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dna-Reagents, Neisseria
510(k) Number K052224
Device Name BD PROBE TEC URINE PRESERVATIVE TRANSPORT
Applicant
Becton, Dickinson & CO
7loveton Cir.
Sparks,  MD  21152
Applicant Contact KATHRYN BABKA POWERS
Correspondent
Becton, Dickinson & CO
7loveton Cir.
Sparks,  MD  21152
Correspondent Contact KATHRYN BABKA POWERS
Regulation Number866.3390
Classification Product Code
LSL  
Subsequent Product Code
MKZ  
Date Received08/16/2005
Decision Date 09/12/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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