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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Panels, Test, Susceptibility, Antimicrobial
510(k) Number K972799
Device Name DRIED GRAM-POSITIVE MIC/COMBO PANELS
Applicant
Dade Microscan, Inc.
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact SHAROLYN J LENTSCH
Correspondent
Dade Microscan, Inc.
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact SHAROLYN J LENTSCH
Regulation Number866.1640
Classification Product Code
LTT  
Date Received07/28/1997
Decision Date 10/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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