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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 K062927
Device Name MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML)
Applicant
DADE BEHRING, INC.
2040 ENTERPRISE BLVD.
WEST SACRAMENTO,  CA  95691
Applicant Contact MAY MORISHIMA
Correspondent
DADE BEHRING, INC.
2040 ENTERPRISE BLVD.
WEST SACRAMENTO,  CA  95691
Correspondent Contact MAY MORISHIMA
Regulation Number866.1640
Classification Product Code
LRG  
Subsequent Product Code
LTT  
Date Received09/28/2006
Decision Date 10/12/2006
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
Recalls CDRH Recalls
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