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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 K062773
Device Name MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN
Applicant
DADE BEHRING, INC.
1584 ENTERPRISE BLVD.
WEST SACRAMENTO,  CA  95691
Applicant Contact LIBBY WARRINER
Correspondent
DADE BEHRING, INC.
1584 ENTERPRISE BLVD.
WEST SACRAMENTO,  CA  95691
Correspondent Contact LIBBY WARRINER
Regulation Number866.1640
Classification Product Code
LTT  
Date Received09/18/2006
Decision Date 10/13/2006
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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