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FDA 510(k) Application Details - K972758
Device Classification Name
System, Blood Culturing
More FDA Info for this Device
510(K) Number
K972758
Device Name
System, Blood Culturing
Applicant
BECTON DICKINSON MICROBIOLOGY SYSTEMS
250 SCHILLING CIRCLE
COCKEYSVILLE, MD 21030-0243 US
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Contact
COLLEEN ROHRBECK
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Regulation Number
866.2560
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Classification Product Code
MDB
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More FDA Info for this Product Code
Date Received
06/16/1997
Decision Date
08/08/1997
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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