FDA Product Code
FDA Product Code DAE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5240
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K150412 | Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator | The Binding Site Group , Ltd. | 2015-08-28 | Traditional | PDF ↗ |
| 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. | 2012-07-11 | Traditional | PDF ↗ |
| K992488 | TOTAL HAEMOLYTIC COMPLEMENT RID KIT | The Binding Site, Ltd. | 1999-09-17 | Traditional | PDF ↗ |
| K974111 | QUIDEL CH50 EQ EIA | Quidel Corp. | 1998-07-29 | Traditional | PDF ↗ |
| K954145 | WAKO AUTOKIT CH50 | Wako Chemicals USA, Inc. | 1995-12-18 | Traditional | PDF ↗ |
| K951639 | COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) | Incstar Corp. | 1995-10-13 | Traditional | PDF ↗ |
Product code DAE · Class II · Immunology. Data: openFDA.