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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 K933885
Device Name ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
Applicant
Alamar Biosciences, Inc.
4110 N. Fwy. Blvd.
Sacramento,  CA  95834
Applicant Contact MICHAEL V LANCASTER
Correspondent
Alamar Biosciences, Inc.
4110 N. Fwy. Blvd.
Sacramento,  CA  95834
Correspondent Contact MICHAEL V LANCASTER
Regulation Number866.1640
Classification Product Code
JWY  
Date Received08/10/1993
Decision Date 11/16/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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