Skip to content

Panels › Immunology › Product code JZJ · Class 1

Prealbumin, Antigen, Antiserum, Control

Regulation 866.5060

0510(k)s in 12 months (11 all time)

0recalls in 12 months (1 all time)

0recalls that name a 510(k)

Get daily alerts for JZJ Sample brief CSV

Top companies in JZJ

Company	510(k)s	Recalls
Atlantic Antibodies	2	0
Kent Laboratories, Inc.	2	0
Abbott Laboratories	1	0
Abbott Laboratories Diagnostic Div	0	1
Behring Diagnostics, Inc.	1	0
The Binding Site, Ltd.	1	0
Boehringer Mannheim Corp.	1	0
Hyland Therapeutic Div., Travenol Laboratories	1	0
Kallestad Diag, A Div. of Erbamont, Inc.	1	0
Randox Laboratories, Ltd.	1	0

Decided	510(k)	Device and applicant	Code
Apr 13, 2000	K000661	RANDOX PREALBUMIN Randox Laboratories, Ltd., IE	JZJ
Jan 9, 1998	K972638	TINA-QUANT PREALBUMIN Boehringer Mannheim Corp.	JZJ
Jun 1, 1995	K951966	HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT Kent Laboratories, Inc.	JZJ
Dec 20, 1991	K913672	PREALBUMIN IMMUNOLOGICAL NL TEST KIT The Binding Site, Ltd.	JZJ
Nov 2, 1988	K884298	SPQ(TM) TEST SYSTEM FOR MICROALBUMIN Atlantic Antibodies	JZJ
Nov 2, 1988	K884297	SPQ(TM) TEST SYSTEM FOR PREALBUMIN Atlantic Antibodies	JZJ
Sep 22, 1988	K883002	QM300 PREALBUMIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc.	JZJ
Nov 1, 1985	K850686	ANTISERUM TO HUMAN PREALBUMIN Kent Laboratories, Inc.	JZJ
Jun 21, 1985	K851912	LASER PREALBUMIN TEST Behring Diagnostics, Inc.	JZJ
May 5, 1983	K821135	PREALBUMIN ENZYME IMMUNOASSAY Abbott Laboratories	JZJ
Feb 3, 1978	K772329	LAS-R HUMAN PREALBUMIN TEST Hyland Therapeutic Div., Travenol Laboratories	JZJ

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.