GNE — Antigen, Latex Agglutination, T. Cruzi Class I
FDA product code GNE covers "Antigen, Latex Agglutination, T. Cruzi", a Class I medical device regulated under 21 CFR 866.3870. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- GNE
- Device Class
- Class I
- Regulation Number
- 866.3870
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K834328 | sero-immuno diagnostics | DAT TEST FOR CHAGAS' DISEASE | March 2, 1984 |