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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 K111205
Device Name MICROSCAN (R) MICROSTREP PLUS (R) PANELS
Applicant
Siemens Healthcare Diagnostics, Inc.
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact SHANNON POPSON
Correspondent
Siemens Healthcare Diagnostics, Inc.
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact SHANNON POPSON
Regulation Number866.1640
Classification Product Code
LRG  
Subsequent Product Codes
JWY   LTW  
Date Received04/29/2011
Decision Date 07/20/2011
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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