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FDA 510(k) Application Details - K972772
Device Classification Name
Susceptibility Test Powders, Antimycobacterial
More FDA Info for this Device
510(K) Number
K972772
Device Name
Susceptibility Test Powders, Antimycobacterial
Applicant
TREK DIAGNOSTIC SYSTEMS, INC.
29299 CLEMENS RD., SUITE 1-K
WESTLAKE, OH 44145 US
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Contact
NADINE SULLIVAN
Other 510(k) Applications for this Contact
Regulation Number
866.1640
More FDA Info for this Regulation Number
Classification Product Code
MJA
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More FDA Info for this Product Code
Date Received
07/24/1997
Decision Date
07/13/1999
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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