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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 K101425
Device Name MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES
Applicant
Siemens Healthcare Diagnostics
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact Elisabeth Warriner
Correspondent
Siemens Healthcare Diagnostics
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact Elisabeth Warriner
Regulation Number866.1640
Classification Product Code
LRG  
Subsequent Product Codes
JWY   LTT  
Date Received05/20/2010
Decision Date 09/10/2010
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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