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FDA 510(k)

Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20

K-Number: K232276 · 2023-10-06

ApplicantOxoid Limited (Part of Thermo Fisher Scientific)
Decision Date2023-10-06
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 is a medical device manufactured by Oxoid Limited (Part of Thermo Fisher Scientific). It received FDA 510(k) clearance on 2023-10-06 under approval number K232276. 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 Sulbactam/Durlobactam Disc (10/10 µg) SUD20?

Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 is a medical device that received FDA 510(k) clearance on 2023-10-06. It is manufactured by Oxoid Limited (Part of Thermo Fisher Scientific). The 510(k) number is K232276.

When was Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 approved by the FDA?

Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 received FDA 510(k) clearance on 2023-10-06, under approval number K232276.

What company makes Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20?

Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 is manufactured by Oxoid Limited (Part of Thermo Fisher Scientific).

What is the FDA product code for Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20?

The FDA product code for Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 is 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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