Panels › Immunology › Product code CZP · Class 2

Iga, Antigen, Antiserum, Control

Regulation 866.5510

0510(k)s in 12 months (54 all time)

0recalls in 12 months (3 all time)

3recalls that name a 510(k)

Top companies in CZP

Company	510(k)s	Recalls
Abbott Laboratories	3	1
Boehringer Mannheim Corp.	3	0
Kallestad Laboratories, Inc.	3	0
Atlantic Antibodies	2	0
Dako Corp.	2	0
E.I. Dupont DE Nemours & Co., Inc.	2	0
Helena Laboratories	2	0
Icl Scientific	2	0
Instrumentation Laboratory CO	2	0
Randox Laboratories, Ltd.	1	1

Decided	510(k)	Device and applicant	Code
Dec 22, 1977	K772251	IMMUNOGLOBULIN A NEPHEL. ASSAY Kallestad Laboratories, Inc.	CZP
Sep 15, 1977	K771603	IMMOCHEMISTRY SYSTEM Beckman Instruments, Inc.	CZP
Jun 24, 1977	K770962	GOAT ANTISERUM IGA NEPHELOMETRIC Kallestad Laboratories, Inc.	CZP
Jul 20, 1976	K760146	SERUM, IGA GOAT ANTI-HUMAN ACID Oxford Laboratories, Inc.	CZP

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