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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 K021339
Device Name HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE
Applicant
Trek Diagnostic Systems, Inc.
29299 Clemens Rd. Suite 1-K
Westlake,  OH  44145
Applicant Contact CYNITHIA C KNAPP
Correspondent
Trek Diagnostic Systems, Inc.
29299 Clemens Rd. Suite 1-K
Westlake,  OH  44145
Correspondent Contact CYNITHIA C KNAPP
Regulation Number866.1640
Classification Product Code
JWY  
Date Received03/07/2002
Decision Date 05/09/2002
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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