DAS · Class I · 21 CFR 866.5530

FDA Product Code DAS: Igg (fc Fragment Specific), Antigen, Antiserum, Control

Leading manufacturers include Kent Laboratories, Inc., The Binding Site, Ltd. and Inova Diagnostics, Inc..

8
Total
8
Cleared
77d
Avg days
1976
Since

FDA 510(k) Cleared Igg (fc Fragment Specific), Antigen, Antiserum, Control Devices (Product Code DAS)

8 devices
1–8 of 8
Cleared Sep 04, 1998
PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT
K982023
Inova Diagnostics, Inc.
Immunology · 87d
Cleared Nov 08, 1989
HUMAN (IGG) SUBCLASS (EIA) KIT
K895600
The Binding Site, Ltd.
Immunology · 51d
Cleared Aug 22, 1979
ANTISERUM TO HUMAN IG G FC FRAGMENTS
K790708
Kent Laboratories, Inc.
Immunology · 132d
Cleared Aug 16, 1979
ANTISERUM TO HUMAN FC
K790715
Kent Laboratories, Inc.
Microbiology · 126d

About Product Code DAS - Regulatory Context