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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 K012351
Device Name BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY
Applicant
BECTON DICKINSON & CO.
7 LOVETON CIR.
SPARKS,  MD  21152 -0999
Applicant Contact COLLEEN A ROHRBECK
Correspondent
BECTON DICKINSON & CO.
7 LOVETON CIR.
SPARKS,  MD  21152 -0999
Correspondent Contact COLLEEN A ROHRBECK
Regulation Number866.3390
Classification Product Code
LSL  
Subsequent Product Code
MKZ  
Date Received07/25/2001
Decision Date 09/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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