GTHClass II
Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae
21 CFR 866.3390 / Microbiology
GTH is the FDA product code for Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae, a class II device type, regulated under 21 CFR 866.3390. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- GTH
- Device name
- Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae
- Regulation
- 21 CFR 866.3390
- Device class
- Class II
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 3
- Ingested recalls
- 0
Clearances, product code GTH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1986 | 1 |
| 1990 | 1 |
Applicants with the most clearances
Product code GTH| Applicant | Clearances |
|---|---|
| Baxter Healthcare Corporation | 1 |
| Clinical Sciences, Inc. | 1 |
| Syva Co. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code GTH.
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