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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Panels, Test, Susceptibility, Antimicrobial
510(k) Number K091949
Device Name MICROSCAN MICROSTREP PLUS, MODEL B1027-201
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
1584 ENTERPRISE BLVD
WEST SACRAMENTO,  CA  95691
Applicant Contact SHANNON POPSON
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
1584 ENTERPRISE BLVD
WEST SACRAMENTO,  CA  95691
Correspondent Contact SHANNON POPSON
Regulation Number866.1640
Classification Product Code
LTT  
Subsequent Product Code
LRG  
Date Received07/01/2009
Decision Date 01/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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