Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20

Susceptibility Test Discs, Antimicrobial

Oxoid Limited (part Of Thermo Fisher Scientific)

The following data is part of a premarket notification filed by Oxoid Limited (part Of Thermo Fisher Scientific) with the FDA for Thermo Scientific Oxoid Lefamulin Disc (20µg) Lmu20.

Pre-market Notification Details

Device IDK210873
510k NumberK210873
Device Name:Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20
ClassificationSusceptibility Test Discs, Antimicrobial
Applicant Oxoid Limited (part Of Thermo Fisher Scientific) Wade Road Basingstoke,  GB Rg24 8pw
ContactPhilip Brame
CorrespondentAmie Lovatt
Oxoid Limited (part Of Thermo Fisher Scientific) Wade Road Basingstoke,  GB Rg24 8pw
Product CodeJTN  
CFR Regulation Number866.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-24
Decision Date2021-10-27

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