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FDA 510(k) Application Details - K013368
Device Classification Name
Panels, Test, Susceptibility, Antimicrobial
More FDA Info for this Device
510(K) Number
K013368
Device Name
Panels, Test, Susceptibility, Antimicrobial
Applicant
TREK DIAGNOSTIC SYSTEMS, INC.
29299 CLEMENS RD., SUITE 1-K
WESTLAKE, OH 44145 US
Other 510(k) Applications for this Company
Contact
CYNTHIA C KNAPP
Other 510(k) Applications for this Contact
Regulation Number
866.1640
More FDA Info for this Regulation Number
Classification Product Code
LTT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/11/2001
Decision Date
11/20/2001
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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