FDA 510(k) Applications for Medical Device Product Code: MJZ (Kit, Direct Antigen, Positive Control)

FDA 510(k) Applications for Medical Device Product Code "MJZ"
(Kit, Direct Antigen, Positive Control)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K972182	ABBOTT DIAGNOSTICS	ABBOTT STREP A CONTROLS	08/13/1997
K083744	BINAX, INC.	BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010	09/01/2009
K972129	BLACKHAWK BIOSYSTEMS, INC.	CHLAMYDIATROL AG	08/12/1997