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FDA 510(k)

Great Basin Toxigenic C. difficile Direct Test (CDF2)

K-Number: K232092 · 2023-11-14

ApplicantVela Operations USA
Decision Date2023-11-14
Product CodeOZN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Great Basin Toxigenic C. difficile Direct Test (CDF2) is a medical device manufactured by Vela Operations USA. It received FDA 510(k) clearance on 2023-11-14 under approval number K232092. The device is classified under product code OZN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Great Basin Toxigenic C. difficile Direct Test (CDF2)?

Great Basin Toxigenic C. difficile Direct Test (CDF2) is a medical device that received FDA 510(k) clearance on 2023-11-14. It is manufactured by Vela Operations USA. The 510(k) number is K232092.

When was Great Basin Toxigenic C. difficile Direct Test (CDF2) approved by the FDA?

Great Basin Toxigenic C. difficile Direct Test (CDF2) received FDA 510(k) clearance on 2023-11-14, under approval number K232092.

What company makes Great Basin Toxigenic C. difficile Direct Test (CDF2)?

Great Basin Toxigenic C. difficile Direct Test (CDF2) is manufactured by Vela Operations USA.

What is the FDA product code for Great Basin Toxigenic C. difficile Direct Test (CDF2)?

The FDA product code for Great Basin Toxigenic C. difficile Direct Test (CDF2) is OZN.

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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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