FDA product code NNK: Container, Specimen Mailer And Storage, Non-Sterile
NNK is the FDA product code for container, specimen mailer and storage, non-sterile. It is a Class I device, regulated under 21 CFR 864.3250 and reviewed by the Pathology panel. Devices under NNK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Container, Specimen Mailer And Storage, Non-Sterile |
| Device class | Class I |
| Regulation | 21 CFR 864.3250 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for NNK devices
openFDA lists no recalls for product code NNK.
Frequently asked questions
What is FDA product code NNK?
NNK is the FDA product code for container, specimen mailer and storage, non-sterile. It is a Class I device, regulated under 21 CFR 864.3250 and reviewed by the Pathology panel.
What device class is NNK?
Class I, regulation 21 CFR 864.3250. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NNK
- Run a recall and safety report across every NNK manufacturer
- Watch product code NNK 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 Pathology product codes · FDA product code lookup · 510(k) database search · 510(k) review times