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Panels › Immunology › Product code DER · Class 2

Alpha-1-Lipoprotein, Antigen, Antiserum, Control

Regulation 866.5580

0510(k)s in 12 months (17 all time)

0recalls in 12 months (2 all time)

2recalls that name a 510(k)

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Top companies in DER

Company	510(k)s	Recalls
Crestat Diagnostics, Inc.	3	0
Photec Diagnostics, Inc.	3	0
Abbott Laboratories	1	1
Kamiya Biomedical Co.	2	0
Roche Diagnostics Corp.	2	0
Abbott Laboratories Diagnostic Div	0	1
Bayer Corp.	1	0
Eucardio Laboratory, Inc.	1	0
Hyland Therapeutic Div., Travenol Laboratories	1	0
Roche Diagnostic Systems, Inc.	1	0

Decided	510(k)	Device and applicant	Code
Nov 16, 2001	K013249	TINA-QUANT APOLIPOPROTEIN VER.2 Roche Diagnostics Corp.	DER
May 18, 2000	K000921	BAYER ADVIA IMS SYSTEM; 200 + 3 Bayer Corp.	DER
Oct 28, 1999	K993354	K-ASSAY APO B Kamiya Biomedical Co.	DER
Oct 25, 1999	K993345	K-ASSAY APO AI Kamiya Biomedical Co.	DER
Apr 14, 1999	K990594	INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 Roche Diagnostics Corp.	DER
Jan 29, 1999	K983289	APOLIPOPROTEIN A1 Abbott Laboratories	DER
Aug 1, 1997	K964296	N-ASSAY TIA APO B TEST KIT Crestat Diagnostics, Inc.	DER
Aug 1, 1997	K964294	N-ASSAY TIA APO A1/B MULTI CALIBRATOR Crestat Diagnostics, Inc.	DER
Aug 1, 1997	K964292	N-ASSAY TIA APO A1 TEST KIT Crestat Diagnostics, Inc.	DER
May 8, 1991	K910553	ROCHE APOLIPOPROTEIN STANDARD Roche Diagnostic Systems, Inc.	DER
Sep 24, 1990	K904125	UC IMU A Eucardio Laboratory, Inc.	DER
Jun 18, 1987	K872078	QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL Solomon Park Research Laboratories	DER
Jan 24, 1986	K854875	APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 Photec Diagnostics, Inc.	DER
Aug 28, 1985	K853048	APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 Photec Diagnostics, Inc.	DER
Jun 5, 1985	K851649	APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1 Photec Diagnostics, Inc.	DER
May 21, 1984	K840830	VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN Ventrex Laboratories, Inc.	DER
Jan 5, 1981	K802610	ALERT A,HDL-APOLIPOROTEIN A, TEST KIT Hyland Therapeutic Div., Travenol Laboratories	DER

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