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

FDA 510(k)

Copan Universal Transport Medium (UTM-RT) System

K-Number: K232357 · 2024-04-25

ApplicantCopan Italia Spa
Decision Date2024-04-25
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Copan Universal Transport Medium (UTM-RT) System is a medical device manufactured by Copan Italia Spa. It received FDA 510(k) clearance on 2024-04-25 under approval number K232357. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Copan Universal Transport Medium (UTM-RT) System?

Copan Universal Transport Medium (UTM-RT) System is a medical device that received FDA 510(k) clearance on 2024-04-25. It is manufactured by Copan Italia Spa. The 510(k) number is K232357.

When was Copan Universal Transport Medium (UTM-RT) System approved by the FDA?

Copan Universal Transport Medium (UTM-RT) System received FDA 510(k) clearance on 2024-04-25, under approval number K232357.

What company makes Copan Universal Transport Medium (UTM-RT) System?

Copan Universal Transport Medium (UTM-RT) System is manufactured by Copan Italia Spa.

What is the FDA product code for Copan Universal Transport Medium (UTM-RT) System?

The FDA product code for Copan Universal Transport Medium (UTM-RT) System is JSM.

Related Clinical Trials

NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT06472518 Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs. RECRUITING NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT07581301 Administering Atropine Through Autoinjectors Within Ambulance Services for Poisoning Patients in Sri Lanka's North Central Province NOT_YET_RECRUITING NCT07556588 XVIVO Heart Transplant Study in Clinical Practice RECRUITING NCT05956652 Hydra Registry - Italy Experience RECRUITING

Other Devices by Copan Italia Spa

K180052UriSwab-Urine Collection, Transport and Preservation System K201849eNAT molecular collection and preservation medium K220052Copan FecalSwab Collection, Transport and Preservation System K232565UriSponge™

Related Devices (Code: JSM)

K162284Puritan Fecal Opti-Swab Collection and Transport SystemPuritan Medical Products, LLC K160082Puritan Opti-Tranz Cary-Blair Collection and Transport SystemPuritan Medical Products, LLC K163436Greiner Vacuette Urine Count and Culture, Mannitol tubeGreiner Bio-One Na, Inc. K180052UriSwab-Urine Collection, Transport and Preservation SystemCopan Italia Spa K201674Cultura Collection and Transport SystemMerit Medical Systems, Inc. K220052Copan FecalSwab Collection, Transport and Preservation SystemCopan Italia Spa

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.

↑