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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 K905853
Device Name ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
Applicant
Alamar Biosciences Laboratory, Inc.
3401 La Grande Blvd.
Sacramento,  CA  95823
Applicant Contact MICHAEL V LANCASTER
Correspondent
Alamar Biosciences Laboratory, Inc.
3401 La Grande Blvd.
Sacramento,  CA  95823
Correspondent Contact MICHAEL V LANCASTER
Regulation Number866.1640
Classification Product Code
JWY  
Date Received12/18/1990
Decision Date 02/07/1991
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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