FDA product code GTO: Anti-Streptokinase
GTO is the FDA product code for anti-streptokinase. It is a Class I device, regulated under 21 CFR 866.3720 and reviewed by the Microbiology panel. Devices under GTO reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Anti-Streptokinase |
| Device class | Class I |
| Regulation | 21 CFR 866.3720 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GTO devices
openFDA lists no recalls for product code GTO.
Frequently asked questions
What is FDA product code GTO?
GTO is the FDA product code for anti-streptokinase. It is a Class I device, regulated under 21 CFR 866.3720 and reviewed by the Microbiology panel.
What device class is GTO?
Class I, regulation 21 CFR 866.3720. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GTO
- Run a recall and safety report across every GTO manufacturer
- Watch product code GTO 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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