FDA 510(k) Application Details - K232892

Device Classification Name	Campylobacter Pylori   More FDA Info for this Device
510(K) Number	K232892
Device Name	Campylobacter Pylori
Applicant	Biomerica, Inc. 17571 Von Karman Avenue Irvine, CA 92614 US Other 510(k) Applications for this Company
Contact	Bonnie Qiu Other 510(k) Applications for this Contact
Regulation Number	866.3110   More FDA Info for this Regulation Number
Classification Product Code	LYR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/2023
Decision Date	12/15/2023
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