ANTIMICROBIAL GENTAMICIN

Manual Antimicrobial Susceptibility Test Systems

ALAMAR BIOSCIENCES LABORATORY, INC.

The following data is part of a premarket notification filed by Alamar Biosciences Laboratory, Inc. with the FDA for Antimicrobial Gentamicin.

Pre-market Notification Details

Device IDK911305
510k NumberK911305
Device Name:ANTIMICROBIAL GENTAMICIN
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant ALAMAR BIOSCIENCES LABORATORY, INC. 3401 LA GRANDE BLVD. Sacramento,  CA  95823
ContactMichael V Lancaster
CorrespondentMichael V Lancaster
ALAMAR BIOSCIENCES LABORATORY, INC. 3401 LA GRANDE BLVD. Sacramento,  CA  95823
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-25
Decision Date1991-04-22

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