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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Screening, Staphylococcus Aureus
510(k) Number K926173
Device Name STAPH-A-LEX(TM) SYSTEM
Applicant
Trinity Laboratories, Inc.
7517 Precision Dr., #107
Raleigh,  NC  27613
Applicant Contact BRUCE A CLINTON
Correspondent
Trinity Laboratories, Inc.
7517 Precision Dr., #107
Raleigh,  NC  27613
Correspondent Contact BRUCE A CLINTON
Regulation Number866.2660
Classification Product Code
JWX  
Date Received12/08/1992
Decision Date 08/10/1993
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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