Method, Immunodiffusion, Immunoglobulins (G, A, M)
FDA product code CGM · Class II (moderate risk) · 21 CFR 866.5510 · Immunology
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K915650 | Human Igg Subclass Rid KitCGM · Traditional | Janssen Biochimica | 03/26/1992SE |
| K920006 | Il Test Immunoglobulin G (Igg)CGM · Traditional | Instrumentation Laboratory CO | 03/13/1992SE |
| K920370 | Isotypes Human Igg Subclass Eia KitCGM · Traditional | Isotypes, Inc. | 03/11/1992SE |
| K920008 | Il Test Immunoglobulin M (Igm)CGM · Traditional | Instrumentation Laboratory CO | 03/11/1992SE |