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FDA 510(k)

Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30

K-Number: K181975 · 2018-09-27

ApplicantOxoid Limited (Part of Thermo Fisher Scientific)
Decision Date2018-09-27
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 is a medical device manufactured by Oxoid Limited (Part of Thermo Fisher Scientific). It received FDA 510(k) clearance on 2018-09-27 under approval number K181975. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30?

Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 is a medical device that received FDA 510(k) clearance on 2018-09-27. It is manufactured by Oxoid Limited (Part of Thermo Fisher Scientific). The 510(k) number is K181975.

When was Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 approved by the FDA?

Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 received FDA 510(k) clearance on 2018-09-27, under approval number K181975.

What company makes Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30?

Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 is manufactured by Oxoid Limited (Part of Thermo Fisher Scientific).

What is the FDA product code for Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30?

The FDA product code for Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 is JTN.

Other Devices by Oxoid Limited (Part of Thermo Fisher Scientific)

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Related Devices (Code: JTN)

K172621HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)Hardy Diagnostics K171975HardyDisk AST Delafloxacin 5 µg (DLX5)Hardy Diagnostics K170127HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40Hardy Diagnostics K182357HardyDisk AST Eravacycline 20µg (ERV20)Hardy Diagnostics K181700HardyDisk AST Plazomicin 30ug (PLZ30)Hardy Diagnostics K192326HardyDisk AST Lefamulin 20µg (LMU20)Hardy Diagnostics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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