DEWClass II

Igg, Antigen, Antiserum, Control

21 CFR 866.5510 / Immunology

DEW is the FDA product code for Igg, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5510. As of 2026-09-10, FDA records hold 76 510(k) clearances under this code, the most recent dated 2005-02-08, and 4 recalls.

Classification record

Product code: DEW
Device name: Igg, Antigen, Antiserum, Control
Regulation: 21 CFR 866.5510
Device class: Class II
Review panel: Immunology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 76
Ingested recalls: 4

Clearances, product code DEW

By decision year

76 clearances under product code DEW with a decision year between 1976 and 2005, 1981 the highest year at 9.

Show the numbers

510(k) clearances under FDA product code DEW by decision year
Year	Clearances
1976	1
1977	7
1978	1
1979	6
1980	6
1981	9
1982	2
1983	4
1984	3
1985	4
1986	2
1987	4
1988	5
1989	3
1990	1
1991	1
1992	2
1993	1
1994	2
1995	1
1996	2
1997	3
1998	1
1999	1
2000	1
2001	1
2004	1
2005	1

Applicants with the most clearances

Product code DEW

Applicants holding the most 510(k) clearances under product code DEW
Applicant	Clearances
Kent Laboratories, Inc.	5
Beckman Instruments, Inc.	4
Icl Scientific	4
Abbott Medical	3
Dako Corp.	3
Diagnostica, Inc.	3
Helena Laboratories, Corp.	3
E.I. Dupont de Nemours & Co., Inc.	2
Gelco Diagnostics, Inc.	2
Kallestad Diag, A Div. of Erbamont, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order