Panels › Immunology › Product code DAE · Class 2
Complement C9, Antigen, Antiserum, Control
Regulation 866.5240
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DAE
| Company | 510(k)s | Recalls |
|---|---|---|
| The Binding Site Group , Ltd. | 2 | 0 |
| The Binding Site, Ltd. | 1 | 0 |
| Incstar Corp. | 1 | 0 |
| Quidel Corp. | 1 | 0 |
| Wako Chemicals USA, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 28, 2015 | K150412 | Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator The Binding Site Group , Ltd., GB | DAE |
| Jul 11, 2012 | K113349 | HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO The Binding Site Group , Ltd., GB | DAE |
| Sep 17, 1999 | K992488 | TOTAL HAEMOLYTIC COMPLEMENT RID KIT The Binding Site, Ltd. | DAE |
| Jul 29, 1998 | K974111 | QUIDEL CH50 EQ EIA Quidel Corp. | DAE |
| Dec 18, 1995 | K954145 | WAKO AUTOKIT CH50 Wako Chemicals USA, Inc. | DAE |
| Oct 13, 1995 | K951639 | COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) Incstar Corp. | DAE |
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