DBM · Class II · 21 CFR 866.5090

FDA Product Code DBM: Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

Leading manufacturers include Inova Diagnostics, Inc. and Phadia AB.

27
Total
27
Cleared
94d
Avg days
1976
Since

FDA 510(k) Cleared Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control Devices (Product Code DBM)

27 devices
1–24 of 27
Cleared Jul 13, 2018
EliA M2 Immunoassay
K181556
Phadia AB
Immunology · 30d
Cleared Sep 05, 2017
QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls
K163525
Inova Diagnostics, Inc.
Immunology · 264d

About Product Code DBM - Regulatory Context