GMN — Antigens, Cf, Toxoplasma Gondii Class II
FDA Device Classification
Classification Details
- Product Code
- GMN
- Device Class
- Class II
- Regulation Number
- 866.3780
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K894261 | microbix biosystems | TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN | October 16, 1989 |
| K864981 | virion (u.s.) | TOXOPLASMA GONDII | October 30, 1987 |
| K791456 | volu sol medical industries | AGGLUTINOTEST-TOXOPLASMOSIS | September 24, 1979 |