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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