MicroScan Dried Gram Negative MIC/Combo Panels With Ciprofloxacin (Cp) (0.004 - 8µg/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 Ciprofloxacin (cp) (0.004 - 8µg/ml).

Pre-market Notification Details

Device IDK193536
510k NumberK193536
Device Name:MicroScan Dried Gram Negative MIC/Combo Panels With Ciprofloxacin (Cp) (0.004 - 8µg/mL)
ClassificationPanels, Test, Susceptibility, Antimicrobial
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 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 Received2019-12-20
Decision Date2020-03-18

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