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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, automated, antimicrobial susceptibility, short incubation
510(k) Number K020246
Device Name MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML)
Applicant
DADE BEHRING, INC.
1584 ENTERPRISE BLVD.
WEST SACRAMENTO,  CA  95691
Applicant Contact MAUREEN MENDE
Correspondent
DADE BEHRING, INC.
1584 ENTERPRISE BLVD.
WEST SACRAMENTO,  CA  95691
Correspondent Contact MAUREEN MENDE
Regulation Number866.1645
Classification Product Code
LON  
Date Received01/24/2002
Decision Date 02/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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