FDA product code GMT: Antigens, Ha, Treponema Pallidum
GMT is the FDA product code for antigens, ha, treponema pallidum. It is a Class II device, regulated under 21 CFR 866.3830 and reviewed by the Microbiology panel. FDA has cleared 9 510(k) submissions under GMT, from 8 different applicants. The average 510(k) review took 121 days (median 107).
Classification
| Field | Value |
|---|---|
| Device name | Antigens, Ha, Treponema Pallidum |
| Device class | Class II |
| Regulation | 21 CFR 866.3830 |
| 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 GMT clearance
Top GMT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympus Corp. | 2 | 1991-07-24 |
| Scimedx Tekfile Services | 1 | 1997-11-13 |
| Fujirebio America, Inc. | 1 | 1991-05-06 |
| Behring Diagnostics, Inc. | 1 | 1990-05-15 |
| Fujirebio Diagnostics,Inc. | 1 | 1989-11-17 |
3 more applicants have GMT clearances. See the full list in Caduvo.
Most recent GMT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K971502 | Scimedx Tekfile Services | SERODIA TP-PA | 1997-11-13 | 203 |
| K911640 | Olympus Corp. | OLYMPUS PK TP(TM) SYSTEM, MODIFICATION | 1991-07-24 | 107 |
| K911266 | Olympus Corp. | MODIFIED PK TP CONTROL | 1991-05-07 | 53 |
| K905038 | Fujirebio America, Inc. | OLYMPUS PK-TP ABSORBENT KIT | 1991-05-06 | 181 |
| K896410 | Behring Diagnostics, Inc. | CELLOGNOST SYPHILIS H | 1990-05-15 | 189 |
Recalls for GMT devices
openFDA lists no recalls for product code GMT.
Frequently asked questions
What is FDA product code GMT?
GMT is the FDA product code for antigens, ha, treponema pallidum. It is a Class II device, regulated under 21 CFR 866.3830 and reviewed by the Microbiology panel.
What device class is GMT?
Class II, regulation 21 CFR 866.3830. Typical premarket route: 510(k).
How long does a 510(k) take for product code GMT?
Across 9 cleared submissions the average was 121 days from receipt to decision (median 107).
Which companies have the most GMT clearances?
Olympus Corp. (2); Scimedx Tekfile Services (1); Fujirebio America, Inc. (1); Behring Diagnostics, Inc. (1); Fujirebio Diagnostics,Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GMT
- Run a recall and safety report across every GMT manufacturer
- Watch product code GMT 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times