KTO — Reagent, Immunoassay, Igg Class I
FDA Device Classification
Classification Details
- Product Code
- KTO
- Device Class
- Class I
- Regulation Number
- 866.5530
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K894416 | reagents applications | RAICHEM(TM) SPIA(TM) IGG REAGENTS | August 1, 1989 |
| K854483 | kallestad laboratories | KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT | December 11, 1985 |