FDA 510(k) Application Details - K232092

Device Classification Name	More FDA Info for this Device
510(K) Number	K232092
Device Name	Great Basin Toxigenic C. difficile Direct Test (CDF2)
Applicant	Vela Operations USA 2441 South 3850 West Salt Lake City, UT 84120 US Other 510(k) Applications for this Company
Contact	Larry Rea Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/13/2023
Decision Date	11/14/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review