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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
Original Applicant
BECTON DICKINSON & CO.
7 loveton cir.
sparks,  MD  21152 0999
Original 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 (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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