DEW · Class II · 21 CFR 866.5510

FDA Product Code DEW: Igg, Antigen, Antiserum, Control

Leading manufacturers include Kent Laboratories, Inc., Dako Corp. and Beckman Instruments, Inc..

76
Total
76
Cleared
58d
Avg days
1976
Since
76 devices
49–72 of 76
Cleared Apr 12, 1979
ANTISERUM TO HUMAN IGG
K790704
Kent Laboratories, Inc.
Immunology
Cleared Dec 22, 1977
IMMUNOGLOBULIN G NEPHEL. ASSAY
K772252
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Jun 24, 1977
GOAT ANTISERUM IGG NEPHELOMETRIC
K770961
Kallestad Laboratories, Inc.
Immunology · 28d
Cleared Apr 28, 1977
DASP TM ANTI-RABBIT
K770597
Organon, Inc.
Immunology · 30d
Cleared Apr 28, 1977
FLUORESCEIN CONJUGATED ANTISERUM
K770668
Kent Laboratories, Inc.
Immunology · 20d
Cleared Apr 28, 1977
RHODAMINE-CONJUGATED ANTISERUM
K770669
Kent Laboratories, Inc.
Immunology · 20d
Cleared Apr 07, 1977
ULTRA LOW LEVEL IMMUNOGLOBULIN G
K761224
Intl. Diagnostic Technology
Immunology · 120d
Cleared Mar 21, 1977
FLUOR. CONJUGATED ANTISERUM
K770484
Kent Laboratories, Inc.
Immunology · 7d