Ige, Fitc, Antigen, Antiserum, Control
FDA product code DGP · Class II (moderate risk) · 21 CFR 866.5510 · Immunology
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K931224 | Vidas Total Ige (Ige) AssayDGP · Traditional | Biomerieux Vitek, Inc. | 05/20/1993SE |
| K863327 | Immpulse Ige Assay ReagentsDGP · Traditional | Sclavo, Inc. | 12/03/1986SE |
| K842969 | Allergenetics Aller-Specific Ige SerumDGP · Traditional | Allergenetics | 08/28/1984SE |
| K842749 | Fiax Total Ige Test KitDGP · Traditional | Intl. Diagnostic Technology | 08/28/1984SE |