FDA 510(k)

Great Basin Toxigenic C. difficile Direct Test (CDF2)

Número K: K232092 · 2023-11-14

Data da decisão2023-11-14

Código do produtoOZN

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Vela Operations USA. The 510(k) number is K232092.

When did Great Basin Toxigenic C. difficile Direct Test (CDF2) receive FDA 510(k) clearance?

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

Who is the listed applicant for Great Basin Toxigenic C. difficile Direct Test (CDF2)?

The FDA 510(k) record lists Vela Operations USA as the applicant. This does not by itself establish the device manufacturer.

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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