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

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 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 2022-09-15 under 510(k) 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. The listed applicant is Oxoid Limited (Part of Thermo Fisher Scientific). The 510(k) number is K203336.

When did Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 receive FDA 510(k) clearance?

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

Who is the listed applicant for Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30?

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 Omadacycline Disc (30 ug) OMC30?

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

Other records listing Oxoid Limited (Part of Thermo Fisher Scientific) as applicant

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.

K231806Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5K232276Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20K210873Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20K203700Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30K193508Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20K181975Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30

View all 7 devices →

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.

K261781Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60Thermo Fisher Scientific (Oxoid Ltd.)K261853Gepotidacin GEP 10 µgLiofilchem, Inc.K260842HardyDisk AST Gepotidacin 10µg (GEP10)Hardy DiagnosticsK251337Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10Thermo Fisher Scientific (Oxoid Ltd.)K253105HardyDisk AST Cefiderocol 30µg (FDC30)Hardy DiagnosticsK251879Sulopenem SPM 2 µgLiofilchem

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.

↑