LLA — Direct Agglutination Test, Toxoplasma Gondii Class II
FDA Device Classification
Classification Details
- Product Code
- LLA
- 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 |
|---|
| K913467 | biokit usa | TOXOGEN | January 11, 1993 |
| K890048 | ampcor | QUIK-DOT TOXOPLASMOSIS | June 9, 1989 |
| K850768 | bd becton dickinson vacutainer systems preanalytic | TOXOSCAN CARD TEST KIT | May 20, 1985 |
| K831930 | bd becton dickinson vacutainer systems preanalytic | TOXO-SCREEN DA TEST | September 26, 1983 |