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FDA 510(k) Application Details - K011400
Device Classification Name
System,Test,Genotypic Detection,Resistant Markers,Staphylococcus Colonies
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510(K) Number
K011400
Device Name
System,Test,Genotypic Detection,Resistant Markers,Staphylococcus Colonies
Applicant
DENKA SEIKEN'S
3-4-2 NIHONBASHI
KAYABACHO, CHUO-KU
TOKYO 103-0025 JP
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Contact
KEVIN MANGAN
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Regulation Number
866.1640
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Classification Product Code
MYI
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More FDA Info for this Product Code
Date Received
05/07/2001
Decision Date
03/27/2002
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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