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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 K970676
Device Name DRIED GRAM-NEGATIVE MIC/COMBO PANELS
Applicant
Dade Intl., Inc.
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact SHAROLYN J LENTSCH
Correspondent
Dade Intl., Inc.
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact SHAROLYN J LENTSCH
Regulation Number866.1640
Classification Product Code
JWY  
Date Received02/24/1997
Decision Date 05/02/1997
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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