MicroScan Dried Gram Negative MIC/Combo Panels With Meropenem (Mer) (0.004-32ug/mL)

Manual Antimicrobial Susceptibility Test Systems

Beckman Coulter, Inc.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Microscan Dried Gram Negative Mic/combo Panels With Meropenem (mer) (0.004-32ug/ml).

Pre-market Notification Details

Device IDK192355
501k NumberK192355
Device Name:MicroScan Dried Gram Negative MIC/Combo Panels With Meropenem (Mer) (0.004-32ug/mL)
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant Beckman Coulter, Inc. 1584 Enterprise Blvd. West Sacramento,  CA  95691
ContactElaine Duncan
CorrespondentElaine Duncan
Beckman Coulter, Inc. 1584 Enterprise Blvd. West Sacramento,  CA  95691
Product CodeJWY  
Subsequent Product CodeLRG
Subsequent Product CodeLTT
Subsequent Product CodeLTW
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyMicrobiology
501k Review PanelMicrobiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-29
Decision Date2019-11-14

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