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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 K001558
Device Name SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN)
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 Received05/19/2000
Decision Date 07/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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