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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name C. Difficile Toxin Gene Amplification Assay
510(k) Number K232092
Device Name Great Basin Toxigenic C. difficile Direct Test (CDF2)
Applicant
Vela Operations USA
2441 S. 3850 W.
Salt Lake City,  UT  84120
Applicant Contact Larry Rea
Correspondent
Vela Operations USA
2441 S. 3850 W.
Salt Lake City,  UT  84120
Correspondent Contact Larry Rea
Regulation Number866.3130
Classification Product Code
OZN  
Date Received07/13/2023
Decision Date 11/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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