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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 K944723
Device Name ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATION
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 Received09/26/1994
Decision Date 10/21/1994
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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