DBL · Class II · 21 CFR 866.5660

FDA Product Code DBL: Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

Leading manufacturers include Immuno Concepts, N.A. , Ltd., Zeus Scientific, Inc. and Inova Diagnostics, Inc..

24
Total
24
Cleared
178d
Avg days
1980
Since

FDA 510(k) Cleared Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control Devices (Product Code DBL)

24 devices
1–24 of 24
Cleared Oct 19, 2018
Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts
K180202
Immuno Concepts, N.A. , Ltd.
Immunology · 268d
Cleared Apr 02, 1998
NOVA LITE ENDOMYSIAL
K980312
Inova Diagnostics, Inc.
Immunology · 65d
Cleared Aug 12, 1981
ANTI-SKIN ANTIBODY TEST SYSTEM
K811261
Zeus Scientific, Inc.
Microbiology · 98d

About Product Code DBL - Regulatory Context