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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
510(k) Number K941425
Device Name ALAMAR ANTIBIOTIC SUSCEPTIBILITY
Applicant
Alamar Biosciences Laboratory, Inc.
4110 N. Freeway Blvd.
Sacramento,  CA  95834 -1219
Applicant Contact MICHAEL V LANCASTER, PH.D
Correspondent
Alamar Biosciences Laboratory, Inc.
4110 N. Freeway Blvd.
Sacramento,  CA  95834 -1219
Correspondent Contact MICHAEL V LANCASTER, PH.D
Regulation Number866.1640
Classification Product Code
LRG  
Date Received03/23/1994
Decision Date 12/15/1994
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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