MicroScan Dried Gram-Negative MIC/Combo Panels With Levofloxacin (Lvx) (0.008-16ug/mL)

Panels, Test, Susceptibility, Antimicrobial

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 Levofloxacin (lvx) (0.008-16ug/ml).

Pre-market Notification Details

Device IDK193358
510k NumberK193358
Device Name:MicroScan Dried Gram-Negative MIC/Combo Panels With Levofloxacin (Lvx) (0.008-16ug/mL)
ClassificationPanels, Test, Susceptibility, Antimicrobial
Applicant Beckman Coulter, Inc. 1584 Enterprise Blvd West Sacramento,  CA  95630
ContactElaine Duncan
CorrespondentElaine Duncan
Beckman Coulter, Inc. 1584 Enterprise Blvd West Sacramento,  CA  95630
Product CodeLTT  
Subsequent Product CodeJWY
Subsequent Product CodeLRG
Subsequent Product CodeLTW
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyMicrobiology
510k Review PanelMicrobiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-04
Decision Date2020-03-03

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