DBE · Class II · 21 CFR 866.5120

FDA Product Code DBE: Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control

Leading manufacturers include Zeus Scientific, Inc., Medica Corp. and Clinical Sciences, Inc..

6
Total
6
Cleared
26d
Avg days
1976
Since

FDA 510(k) Cleared Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control Devices (Product Code DBE)

6 devices
1–6 of 6
Cleared Apr 24, 1980
AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY
K800820
Calbiochem-Behring Corp.
Immunology · 13d
Cleared Feb 21, 1980
IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT
K800228
Clinical Sciences, Inc.
Immunology · 16d
Cleared Apr 23, 1979
MEDICA II-F-ASMA TEST KIT
K790430
Medica Corp.
Immunology · 52d
Cleared Jul 20, 1976
TEST, (IVDP) SMOOTHMUSCLE ANTIBODY
K760156
Zeus Scientific, Inc.
Immunology · 18d

About Product Code DBE - Regulatory Context