FDA product code GTN: Antisera, Fluorescent, All Types, Staphylococcus Spp.
GTN is the FDA product code for antisera, fluorescent, all types, staphylococcus spp.. It is a Class I device, regulated under 21 CFR 866.3700 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under GTN, from 3 different applicants. The average 510(k) review took 171 days (median 178).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, All Types, Staphylococcus Spp. |
| Device class | Class I |
| Regulation | 21 CFR 866.3700 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GTN clearance
Top GTN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Oxoid U.S.A., Inc. | 2 | 1986-11-04 |
| Wellcome Diagnostics | 1 | 1985-05-22 |
| Volu Sol Medical Industries | 1 | 1979-09-24 |
Most recent GTN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K855233 | Oxoid U.S.A., Inc. | DIAGNOSTIC REAGENT SET-RPLA | 1986-11-04 | 308 |
| K855236 | Oxoid U.S.A., Inc. | DIAGNOSTIC REAGENT TST-RPLA | 1986-11-04 | 308 |
| K851949 | Wellcome Diagnostics | STAPHAUREX ZL30 | 1985-05-22 | 19 |
| K791453 | Volu Sol Medical Industries | AGGLUTINOTEST-STAPHYLOLISIN | 1979-09-24 | 49 |
Recalls for GTN devices
openFDA lists no recalls for product code GTN.
Frequently asked questions
What is FDA product code GTN?
GTN is the FDA product code for antisera, fluorescent, all types, staphylococcus spp.. It is a Class I device, regulated under 21 CFR 866.3700 and reviewed by the Microbiology panel.
What device class is GTN?
Class I, regulation 21 CFR 866.3700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GTN?
Across 4 cleared submissions the average was 171 days from receipt to decision (median 178).
Which companies have the most GTN clearances?
Oxoid U.S.A., Inc. (2); Wellcome Diagnostics (1); Volu Sol Medical Industries (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GTN
- Run a recall and safety report across every GTN manufacturer
- Watch product code GTN 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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