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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Identification, Enterobacteriaceae
510(k) Number K926002
Device Name ALAMAR BACTERIAL IDENTIFICATION TEST PANEL
Applicant
Alamar Biosciences Laboratory, Inc.
4110 N. Fwy. Blvd.
Sacramento,  CA  95834
Applicant Contact MICHAEL V LANCASTER
Correspondent
Alamar Biosciences Laboratory, Inc.
4110 N. Fwy. Blvd.
Sacramento,  CA  95834
Correspondent Contact MICHAEL V LANCASTER
Regulation Number866.2660
Classification Product Code
JSS  
Date Received11/27/1992
Decision Date 09/23/1993
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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