JWL — Antigen, Treponema Pallidum For Fta-Abs Test Class II
FDA Device Classification
Classification Details
- Product Code
- JWL
- Device Class
- Class II
- Regulation Number
- 866.3830
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K831296 | parasitic disease consultants | POLYCHACO FIA-ABS TEST FOR SYPHILIS | July 26, 1983 |
| K801959 | immuno-diagnostic products | FTA-ABS TEST | October 23, 1980 |
| K802276 | bioware products | FTA-ABS BIOPAK | October 23, 1980 |
| K801928 | miles laboratories | LAB-TEK FTA-ABS KIT | August 20, 1980 |