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FDA 510(k) Application Details - K053243
Device Classification Name
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
More FDA Info for this Device
510(K) Number
K053243
Device Name
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Applicant
TREK DIAGNOSTIC SYSTEMS, INC.
982 KEYNOTE CIRCLE SUITE 6
CLEVELAND, OH 44131 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
LRG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/21/2005
Decision Date
01/20/2006
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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