FDA 510(k) Application Details - K201438

Device Classification Name	Antigens, Nontreponemal, All   More FDA Info for this Device
510(K) Number	K201438
Device Name	Antigens, Nontreponemal, All
Applicant	Arlington Scientific, Inc. (ASI) 1840 North Technology Dr. Springville, UT 84663 US Other 510(k) Applications for this Company
Contact	David Binks Other 510(k) Applications for this Contact
Regulation Number	866.3820   More FDA Info for this Regulation Number
Classification Product Code	GMQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2020
Decision Date	10/21/2020
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