FDA 510(k) Applications for Medical Device Product Code: MJX (Kit, Serological, Positive Control)

FDA 510(k) Applications for Medical Device Product Code "MJX"
(Kit, Serological, Positive Control)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K101434	AALTO SCIENTIFIC LTD.	AUDIT MICROCV PROCALCITONIN LINEARITY	07/22/2010
K972986	BOSTON BIOMEDICA, INC.	ACCURUN 140 RUBELLA IGG POSITIVE CONTROL	10/08/1997
K030067	ORTHO-CLINICAL DIAGNOSTICS	VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS	01/17/2003
K974262	SCANTIBODIES LABORATORY, INC.	SYSCOS IDC - G, IDC, BSC, IDC - G	12/24/1997
K970100	SIMPLICITY DIAGNOSTICS, INC.	TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL	03/10/1997