CZN — Iga, Fitc, Antigen, Antiserum, Control Class II
FDA Device Classification
Classification Details
- Product Code
- CZN
- 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 |
|---|
| K891683 | helena laboratories | TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER | April 12, 1989 |
| K855011 | kallestad laboratories | QUANTIMETRIC PLUS C3 REAGENT KIT | February 26, 1986 |
| K841815 | miles laboratories | OPTIMATE IGA TEST | June 1, 1984 |
| K832262 | gelco diagnostics | FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS | October 31, 1983 |
| K832257 | gelco diagnostics | GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC | October 28, 1983 |
| K831909 | dako | RABBIT ANTISERUM TO HUMAN IGA | July 18, 1983 |
| K831607 | intl. diagnostic technology | FIAX IGA TEST KIT | June 22, 1983 |