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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Susceptibility Test Powders, Antimycobacterial
510(k) Number K972772
Device Name ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING
Applicant
Trek Diagnostic Systems, Inc.
29299 Clemens Rd. Suite 1-K
Westlake,  OH  44145
Applicant Contact NADINE SULLIVAN
Correspondent
Trek Diagnostic Systems, Inc.
29299 Clemens Rd. Suite 1-K
Westlake,  OH  44145
Correspondent Contact NADINE SULLIVAN
Regulation Number866.1640
Classification Product Code
MJA  
Date Received07/24/1997
Decision Date 07/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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