FDA 510(k) Applications for Medical Device Product Code: CZP (Iga, Antigen, Antiserum, Control)

FDA 510(k) Applications for Medical Device Product Code "CZP"
(Iga, Antigen, Antiserum, Control)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K983359	ABBOTT LABORATORIES	IGA	11/04/1998
K060130	BECKMAN COULTER, INC.	IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT	02/13/2006
K955907	BOEHRINGER MANNHEIM CORP.	BOEHRINGER MANNHEIM IGA ASSAY	02/09/1996
K024038	DADE BEHRING, INC.	N LATEX IGA	02/13/2003
K193525	Horiba ABX SAS	Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M	06/26/2020
K962200	INSTRUMENTATION LABORATORY CO.	QUANTEX IGA	09/25/1996
K955794	RANDOX LABORATORIES, LTD.	IGA IMMUNOTURBIDIMETRIC & CALIBRATOR	04/05/1996
K040435	ROCHE DIAGNOSTICS CORP.	ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2	03/10/2004
K993927	WAKO CHEMICALS, USA, INC.	WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD	01/14/2000