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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manual Antimicrobial Susceptibility Test Systems
510(k) Number K003868
Device Name SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
Applicant
TREK DIAGNOSTIC SYSTEMS, INC.
29299 CLEMENS RD., SUITE 1-K
WESTLAKE,  OH  44145
Applicant Contact CYNTHIA C KNAPP
Correspondent
TREK DIAGNOSTIC SYSTEMS, INC.
29299 CLEMENS RD., SUITE 1-K
WESTLAKE,  OH  44145
Correspondent Contact CYNTHIA C KNAPP
Regulation Number866.1640
Classification Product Code
JWY  
Date Received12/14/2000
Decision Date 02/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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