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FDA 510(k)

Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20

K-Number: K210873 · 2021-10-27

ApplicantOxoid Limited (Part of Thermo Fisher Scientific)
Decision Date2021-10-27
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 is the device name listed in this FDA 510(k) record. The listed applicant is Oxoid Limited (Part of Thermo Fisher Scientific). It received FDA 510(k) clearance on 2021-10-27 under 510(k) number K210873. 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 Lefamulin Disc (20µg) LMU20?

Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 is a medical device that received FDA 510(k) clearance on 2021-10-27. The listed applicant is Oxoid Limited (Part of Thermo Fisher Scientific). The 510(k) number is K210873.

When did Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 receive FDA 510(k) clearance?

Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 received FDA 510(k) clearance on 2021-10-27, under 510(k) number K210873.

Who is the listed applicant for Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20?

The FDA 510(k) record lists Oxoid Limited (Part of Thermo Fisher Scientific) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20?

The FDA product code for Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 is JTN.

Other records listing Oxoid Limited (Part of Thermo Fisher Scientific) as applicant

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Related Devices (Code: JTN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261781Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60Thermo Fisher Scientific (Oxoid Ltd.)K261853Gepotidacin GEP 10 µgLiofilchem, Inc.K260842HardyDisk AST Gepotidacin 10µg (GEP10)Hardy DiagnosticsK251337Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10Thermo Fisher Scientific (Oxoid Ltd.)K253105HardyDisk AST Cefiderocol 30µg (FDC30)Hardy DiagnosticsK251879Sulopenem SPM 2 µgLiofilchem

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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