Thermo Scientific Oxoid Omadacycline Disc (30 Ug) OMC30

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 Omadacycline Disc (30 Ug) Omc30.

Pre-market Notification Details

Device IDK203336
510k NumberK203336
Device Name:Thermo Scientific Oxoid Omadacycline Disc (30 Ug) OMC30
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 Received2020-11-12
Decision Date2022-09-15

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