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FDA 510(k) Application Details - K990640
Device Classification Name
System,Test,Genotypic Detection,Resistant Markers,Staphylococcus Colonies
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510(K) Number
K990640
Device Name
System,Test,Genotypic Detection,Resistant Markers,Staphylococcus Colonies
Applicant
ID BIOMEDICAL CORP.
8855 NORTHBROOK COURT
BURNABY, BRITISH COLUMBIA V5J 5J1 CA
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Contact
ROBERT N BRYAN
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Regulation Number
866.1640
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Classification Product Code
MYI
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Date Received
02/26/1999
Decision Date
07/09/1999
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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