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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 K911304
Device Name ANTIMICROBIAL TOBRAMYCIN
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 Received03/25/1991
Decision Date 04/22/1991
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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