GTH — Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae Class II
FDA Device Classification
Classification Details
- Product Code
- GTH
- Device Class
- Class II
- Regulation Number
- 866.3390
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K900546 | baxter healthcare | BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT | June 15, 1990 |
| K861835 | syva | MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST | May 29, 1986 |
| K800328 | clinical sciences | NEISSERIA GONORRHOEAE FLUORO-KIT | March 3, 1980 |