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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 K081182
Device Name MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN
Applicant
Siemens
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Applicant Contact LIBBY WARRINER
Correspondent
Siemens
1584 Enterprise Blvd.
West Sacramento,  CA  95691
Correspondent Contact LIBBY WARRINER
Regulation Number866.1640
Classification Product Code
JWY  
Subsequent Product Codes
LRG   LTT   LTW  
Date Received04/25/2008
Decision Date 08/08/2008
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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