FDA product code KZC: Manual Colony Counter
KZC is the FDA product code for manual colony counter. It is a Class I device, regulated under 21 CFR 866.2180 and reviewed by the Microbiology panel. Devices under KZC reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Manual Colony Counter |
| Device class | Class I |
| Regulation | 21 CFR 866.2180 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for KZC devices
openFDA lists no recalls for product code KZC.
Frequently asked questions
What is FDA product code KZC?
KZC is the FDA product code for manual colony counter. It is a Class I device, regulated under 21 CFR 866.2180 and reviewed by the Microbiology panel.
What device class is KZC?
Class I, regulation 21 CFR 866.2180. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KZC
- Run a recall and safety report across every KZC manufacturer
- Watch product code KZC 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.