CGM · Class II · 21 CFR 866.5510

FDA Product Code CGM: Method, Immunodiffusion, Immunoglobulins (g, A, M)

Leading manufacturers include Instrumentation Laboratory CO, Janssen Biochimica and Isotypes, Inc..

4
Total
4
Cleared
71d
Avg days
1992
Since

FDA 510(k) Cleared Method, Immunodiffusion, Immunoglobulins (g, A, M) Devices (Product Code CGM)

4 devices
1–4 of 4
Cleared Mar 26, 1992
HUMAN IGG SUBCLASS RID KIT
K915650
Janssen Biochimica
Immunology · 99d
Cleared Mar 13, 1992
IL TEST IMMUNOGLOBULIN G (IGG)
K920006
Instrumentation Laboratory CO
Immunology · 71d
Cleared Mar 11, 1992
IL TEST IMMUNOGLOBULIN M (IGM)
K920008
Instrumentation Laboratory CO
Immunology · 69d
Cleared Mar 11, 1992
ISOTYPES HUMAN IGG SUBCLASS EIA KIT
K920370
Isotypes, Inc.
Immunology · 43d

About Product Code CGM - Regulatory Context