Igd, Antigen, Antiserum, Control
FDA product code CZJ · Class II (moderate risk) · 21 CFR 866.5510 · Immunology
8510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K092450 | Human Igd Kit for Use on SpaplusCZJ · Traditional | The Binding Site | 12/28/2009SE |
| K051299 | Igd Diagnostic Test KitsCZJ · Traditional | The Binding Site, Ltd. | 11/23/2005SE |
| K002561 | Sheep Anti-Human Igd Immunofixation Grade KitCZJ · Traditional | The Binding Site, Ltd. | 10/26/2000SE |
| K913671 | Human Igd Immunological NL Test KitCZJ · Traditional | The Binding Site, Ltd. | 12/02/1991SE |
| K883001 | QM300 Calibrator D PackCZJ · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 09/22/1988SE |
| K872834 | Titan Gel Ife Antiserum to IGD-9409 & IGE-9410CZJ · Traditional | Helena Laboratories | 08/12/1987SE |
| K831956 | Determ. Size 72 Radial-Human IgdCZJ · Traditional | Kent Laboratories, Inc. | 07/18/1983SE |
| K772327 | Las-R Human Igd TestCZJ · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 02/28/1978SE |