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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name assay, nucleic acid amplification, growth identification, mycobacterium tuberculosis
510(k) Number K000884
Device Name BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY
Applicant
BECTON DICKINSON BIOSCIENCES
7 LOVETON CIRCLE
SPARKS,  MD  21152
Applicant Contact COLLEEN ROHRBECK
Correspondent
BECTON DICKINSON BIOSCIENCES
7 LOVETON CIRCLE
SPARKS,  MD  21152
Correspondent Contact COLLEEN ROHRBECK
Regulation Number866.3370
Classification Product Code
NDZ  
Date Received03/20/2000
Decision Date 01/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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