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FDA 510(k) Application Details - K063127
Device Classification Name
Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
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510(K) Number
K063127
Device Name
Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
Applicant
ADVANDX, INC.
690 CANTON STREET, SUITE 302
WESTWOOD, MA 02090 US
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Contact
Amy Aulwes
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Regulation Number
866.3740
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Classification Product Code
OAH
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More FDA Info for this Product Code
Date Received
10/13/2006
Decision Date
12/22/2006
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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