FDA 510(k) Applications for Medical Device Product Code: DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control)

FDA 510(k) Applications for Medical Device Product Code "DBL"
(Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K971464	EURO-DIAGNOSTICA AB	IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT	10/29/1997
K180202	Immuno Concepts, NA, Ltd.	Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts	10/19/2018
K980312	INOVA DIAGNOSTICS, INC.	NOVA LITE ENDOMYSIAL	04/02/1998
K971658	JAY H. GELLER	MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT	05/23/1997
K953495	SCIMEDX CORP.	EIA KIT FOR THE DETECTION OF GBM ANTIBODIES	04/10/1996
K963525	SHIELD DIAGNOSTICS, LTD.	DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT	11/07/1996
K955431	THE BINDING SITE, LTD.	RIT LIVER, KIDNEY, STOMACH IFA KIT	04/23/1996
K974169	WIESLAB AB	WIELISA ANTI-GBM TEST SYSTEM	02/17/1998