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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
510(k) Number K981199
Device Name MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN
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
LRG  
Subsequent Product Code
JWY  
Date Received04/02/1998
Decision Date 11/18/1998
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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