Great Basin Toxigenic C. difficile Direct Test (CDF2)— 510(k) K232092

Name: FDA 510(k) clearance K232092
Creator: U.S. Food and Drug Administration
Published: 2023-11-14

Substantially Equivalent

Vela Operations USA

FDA 510(k) clearance K232092 for Great Basin Toxigenic C. difficile Direct Test (CDF2), Substantially Equivalent on 2023-11-14. Applicant: Vela Operations USA. Device class: 2.

Clearance details

Applicant: Vela Operations USA
Product code: Code OZN
Device class: Class 2
Regulation: 21 CFR 866.3130
Advisory panel: Microbiology
Date received: 2023-07-13
Decision date: 2023-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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