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FDA 510(k) Application Details - K973305
Device Classification Name
System, Blood Culturing
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510(K) Number
K973305
Device Name
System, Blood Culturing
Applicant
ORGANON TEKNIKA CORP.
100 AKZO AVE.
DURHAM, NC 27712 US
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Contact
REBECCA A RIVAS
Other 510(k) Applications for this Contact
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
09/03/1997
Decision Date
11/17/1997
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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