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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 K930478
Device Name READAR
Applicant
Alamar Biosciences, Inc.
4110 N. Freeway Blvd.
Sacramento,  CA  95834 -1219
Applicant Contact MICHAEL V LANCASTER
Correspondent
Alamar Biosciences, Inc.
4110 N. Freeway Blvd.
Sacramento,  CA  95834 -1219
Correspondent Contact MICHAEL V LANCASTER
Regulation Number866.1640
Classification Product Code
LRG  
Date Received01/29/1993
Decision Date 10/22/1993
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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