FDA 510(k) Applications for Medical Device Product Code: DER (Alpha-1-Lipoprotein, Antigen, Antiserum, Control)

FDA 510(k) Applications for Medical Device Product Code "DER"
(Alpha-1-Lipoprotein, Antigen, Antiserum, Control)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K983289	ABBOTT LABORATORIES	APOLIPOPROTEIN A1	01/29/1999
K000921	BAYER CORP.	BAYER ADVIA IMS SYSTEM; 200 + 3	05/18/2000
K964292	CRESTAT DIAGNOSTICS, INC.	N-ASSAY TIA APO A1 TEST KIT	08/01/1997
K964294	CRESTAT DIAGNOSTICS, INC.	N-ASSAY TIA APO A1/B MULTI CALIBRATOR	08/01/1997
K964296	CRESTAT DIAGNOSTICS, INC.	N-ASSAY TIA APO B TEST KIT	08/01/1997
K993345	KAMIYA BIOMEDICAL CO.	K-ASSAY APO AI	10/25/1999
K993354	KAMIYA BIOMEDICAL CO.	K-ASSAY APO B	10/28/1999
K990594	ROCHE DIAGNOSTICS CORP.	INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1	04/14/1999
K013249	ROCHE DIAGNOSTICS CORP.	TINA-QUANT APOLIPOPROTEIN VER.2	11/16/2001