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FDA 510(k)

Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20

K-Number: K193508 · 2020-12-04

ApplicantOxoid Limited (Part of Thermo Fisher Scientific)
Decision Date2020-12-04
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 is a medical device manufactured by Oxoid Limited (Part of Thermo Fisher Scientific). It received FDA 510(k) clearance on 2020-12-04 under approval number K193508. 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 Eravacycline Disc (20ug) ERV20?

Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 is a medical device that received FDA 510(k) clearance on 2020-12-04. It is manufactured by Oxoid Limited (Part of Thermo Fisher Scientific). The 510(k) number is K193508.

When was Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 approved by the FDA?

Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 received FDA 510(k) clearance on 2020-12-04, under approval number K193508.

What company makes Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20?

Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 is manufactured by Oxoid Limited (Part of Thermo Fisher Scientific).

What is the FDA product code for Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20?

The FDA product code for Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 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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