FDA 510(k) Application Details - K972772

Device Classification Name Susceptibility Test Powders, Antimycobacterial

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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
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Regulation Number 866.1640

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Classification Product Code MJA
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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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