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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 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 2023-10-06 under 510(k) 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. The listed applicant is Oxoid Limited (Part of Thermo Fisher Scientific). The 510(k) number is K232276.

When did Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 receive FDA 510(k) clearance?

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

Who is the listed applicant for Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20?

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 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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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.

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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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