CZJ — Igd, Antigen, Antiserum, Control Class II
FDA Device Classification
Classification Details
- Product Code
- CZJ
- Device Class
- Class II
- Regulation Number
- 866.5510
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K092450 | binding site | HUMAN IGD KIT FOR USE ON SPAPLUS | December 28, 2009 |
| K051299 | binding site | IGD DIAGNOSTIC TEST KITS | November 23, 2005 |
| K002561 | binding site | SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT | October 26, 2000 |
| K913671 | binding site | HUMAN IGD IMMUNOLOGICAL NL TEST KIT | December 2, 1991 |
| K883001 | kallestad diag, a div. of erbamont | QM300 CALIBRATOR D PACK | September 22, 1988 |
| K872834 | helena laboratories | TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 | August 12, 1987 |
| K831956 | kent laboratories | DETERM. SIZE 72 RADIAL-HUMAN IGD | July 18, 1983 |
| K772327 | hyland therapeutic div., travenol laboratories | LAS-R HUMAN IGD TEST | February 28, 1978 |