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FDA 510(k)

Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30

K-Number: K203336 · 2022-09-15

ApplicantOxoid Limited (Part of Thermo Fisher Scientific)
Decision Date2022-09-15
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 is a medical device manufactured by Oxoid Limited (Part of Thermo Fisher Scientific). It received FDA 510(k) clearance on 2022-09-15 under approval number K203336. 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 Omadacycline Disc (30 ug) OMC30?

Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 is a medical device that received FDA 510(k) clearance on 2022-09-15. It is manufactured by Oxoid Limited (Part of Thermo Fisher Scientific). The 510(k) number is K203336.

When was Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 approved by the FDA?

Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 received FDA 510(k) clearance on 2022-09-15, under approval number K203336.

What company makes Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30?

Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 is manufactured by Oxoid Limited (Part of Thermo Fisher Scientific).

What is the FDA product code for Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30?

The FDA product code for Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 is JTN.

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

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Related Devices (Code: JTN)

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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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