Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Oxoid Limited (Part of Thermo Fisher Scientific). It received FDA 510(k) clearance on 2021-10-27 under approval 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. It is manufactured by Oxoid Limited (Part of Thermo Fisher Scientific). The 510(k) number is K210873.

When was Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 approved by the FDA?

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

What company makes Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20?

Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 is manufactured by Oxoid Limited (Part of Thermo Fisher Scientific).

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 Devices by Oxoid Limited (Part of Thermo Fisher Scientific)

K181975Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 K193508Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 K203700Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 K203336Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 K232276Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 K231806Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5

View all 7 devices →

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 K181975Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30Oxoid Limited (Part of Thermo Fisher Scientific) K182357HardyDisk AST Eravacycline 20µg (ERV20)Hardy Diagnostics K181700HardyDisk AST Plazomicin 30ug (PLZ30)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.

↑