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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 K062290
Device Name MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML)
Applicant
Dade Behring, Inc.
2040 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact SHANNON POPSON
Correspondent
Dade Behring, Inc.
2040 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact SHANNON POPSON
Regulation Number866.1640
Classification Product Code
LRG  
Subsequent Product Code
LTT  
Date Received08/07/2006
Decision Date 09/01/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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