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FDA 510(k) Application Details - K955826
Device Classification Name
Discs, Strips And Reagents, Microorganism Differentiation
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510(K) Number
K955826
Device Name
Discs, Strips And Reagents, Microorganism Differentiation
Applicant
GIBSON LABORATORIES, INC.
1040 MANCHESTER ST.
LEXINGTON, KY 40508 US
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NAOMI BOWLING
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Regulation Number
866.2660
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Classification Product Code
JTO
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Date Received
12/26/1995
Decision Date
02/29/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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