DAE
6 FDA 510(k) clearances · Product code
191 daysmedian time to decision
271 days90th percentile
6clearances measured
FDA profile
- Official device name
- Complement C9, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5240
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator (K150412) | The Binding Site Group , Ltd. | 2015-08-28 |
| HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO (K113349) | The Binding Site Group , Ltd. | 2012-07-11 |
| TOTAL HAEMOLYTIC COMPLEMENT RID KIT (K992488) | The Binding Site, Ltd. | 1999-09-17 |
| QUIDEL CH50 EQ EIA (K974111) | Quidel Corp. | 1998-07-29 |
| WAKO AUTOKIT CH50 (K954145) | Wako Chemicals USA, Inc. | 1995-12-18 |
| COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) (K951639) | Incstar Corp. | 1995-10-13 |
Track DAE automatically
Every clearance here is in the API, with alerts when new ones post.