FDA 510(k) Application Details - K210511

Device Classification Name	Culture Media, For Isolation Of Pathogenic Neisseria   More FDA Info for this Device
510(K) Number	K210511
Device Name	Culture Media, For Isolation Of Pathogenic Neisseria
Applicant	Biomed Diagnostics Incorporated 1388 Antelope Road White City, OR 97503 US Other 510(k) Applications for this Company
Contact	John F Antiabong Other 510(k) Applications for this Contact
Regulation Number	866.2410   More FDA Info for this Regulation Number
Classification Product Code	JTY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/23/2021
Decision Date	10/20/2021
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