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FDA 510(k) Application Details - K000884
Device Classification Name
Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis
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510(K) Number
K000884
Device Name
Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis
Applicant
BECTON DICKINSON BIOSCIENCES
7 LOVETON CIRCLE
SPARKS, MD 21152 US
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Contact
COLLEEN ROHRBECK
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Regulation Number
866.3370
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Classification Product Code
NDZ
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Date Received
03/20/2000
Decision Date
01/19/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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