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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 K894514
Device Name ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
Applicant
Alamar Biosciences Laboratory, Inc.
870 Napa Valley Corp. Way
Suite B
Napa,  CA  94558
Applicant Contact V LANCASTER
Correspondent
Alamar Biosciences Laboratory, Inc.
870 Napa Valley Corp. Way
Suite B
Napa,  CA  94558
Correspondent Contact V LANCASTER
Regulation Number866.1640
Classification Product Code
JWY  
Date Received07/19/1989
Decision Date 11/06/1989
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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