FDA product code GTH: Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae
GTH is the FDA product code for antiserum, fluorescent (direct test), all groups, n. gonorrhoeae. It is a Class II device, regulated under 21 CFR 866.3390 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under GTH, from 3 different applicants. The average 510(k) review took 55 days (median 20).
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae |
| Device class | Class II |
| Regulation | 21 CFR 866.3390 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GTH clearance
Top GTH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Baxter Healthcare Corp | 1 | 1990-06-15 |
| Syva Co. | 1 | 1986-05-29 |
| Clinical Sciences, Inc. | 1 | 1980-03-03 |
Most recent GTH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K900546 | Baxter Healthcare Corp | BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT | 1990-06-15 | 130 |
| K861835 | Syva Co. | MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST | 1986-05-29 | 16 |
| K800328 | Clinical Sciences, Inc. | NEISSERIA GONORRHOEAE FLUORO-KIT | 1980-03-03 | 20 |
Recalls for GTH devices
openFDA lists no recalls for product code GTH.
Frequently asked questions
What is FDA product code GTH?
GTH is the FDA product code for antiserum, fluorescent (direct test), all groups, n. gonorrhoeae. It is a Class II device, regulated under 21 CFR 866.3390 and reviewed by the Microbiology panel.
What device class is GTH?
Class II, regulation 21 CFR 866.3390. Typical premarket route: 510(k).
How long does a 510(k) take for product code GTH?
Across 3 cleared submissions the average was 55 days from receipt to decision (median 20).
Which companies have the most GTH clearances?
Baxter Healthcare Corp (1); Syva Co. (1); Clinical Sciences, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GTH
- Run a recall and safety report across every GTH manufacturer
- Watch product code GTH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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