Complement C9, Antigen, Antiserum, Control
FDA product code DAE · Class II (moderate risk) · 21 CFR 866.5240 · Immunology
6510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K150412 | Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 CalibratorDAE · Traditional | The Binding Site Group , Ltd. | 08/28/2015SE |
| K113349 | Human CH50 Reagent Pack for Use on the Spaplus, Human CH50 Calibrator Set for Use on the…DAE · Traditional | The Binding Site Group , Ltd. | 07/11/2012SE |
| K992488 | Total Haemolytic Complement Rid KitDAE · Traditional | The Binding Site, Ltd. | 09/17/1999SE |
| K974111 | Quidel CH50 Eq EiaDAE · Traditional | Quidel Corp. | 07/29/1998SE |
| K954145 | Wako Autokit CH50DAE · Traditional | Wako Chemicals USA, Inc. | 12/18/1995SE |
| K951639 | Complement Activation Eia Test System (Cae)DAE · Traditional | Incstar Corp. | 10/13/1995SE |