DAE — Complement C9, Antigen, Antiserum, Control Class II
FDA Device Classification
Classification Details
- Product Code
- DAE
- Device Class
- Class II
- Regulation Number
- 866.5240
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K150412 | binding site group | Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator | August 28, 2015 |
| K113349 | binding site group | HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR US | July 11, 2012 |
| K992488 | binding site | TOTAL HAEMOLYTIC COMPLEMENT RID KIT | September 17, 1999 |
| K974111 | quidel | QUIDEL CH50 EQ EIA | July 29, 1998 |
| K954145 | wako chemicals usa | WAKO AUTOKIT CH50 | December 18, 1995 |
| K951639 | incstar | COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) | October 13, 1995 |