FDA 510(k) Applications for Medical Device Product Code: GMQ (Antigens, Nontreponemal, All)

FDA 510(k) Applications for Medical Device Product Code "GMQ"
(Antigens, Nontreponemal, All)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K182391	Arlington Scientific, Inc. (ASI)	ASI Automated ASI RPR Test for Syphilis on the ASI Evolution	11/30/2018
K201438	Arlington Scientific, Inc. (ASI)	ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer	10/21/2020
K173376	Arlington Scientific, Inc. (ASI)	ASI Evolution	06/14/2018
K992124	AVANTI POLAR LIPIDS, INC.	AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI	09/20/1999
K000687	BEACON BIOLOGICALS, INC.	THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST	06/12/2000
K952802	BIOMIRA DIAGNOSTICS, INC.	VISUWELL REAGIN II	05/23/1996
K993633	CENTERS FOR DISEASE CONTROL AND PREVENTION	SYNTHETIC VDRL ANTIGEN	02/23/2000
K150358	GOLD STANDARD DIAGNOSTICS	Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System	11/12/2015
K954994	GUARDIAN SCIENTIFIC, CORP.	TRUST	10/18/1996
K955136	REMEL, L.P.	RPR CARD TEST KIT	07/29/1996