FDA product code MNM: Reader, Cervical Cytology Slide, Automated
MNM is the FDA product code for reader, cervical cytology slide, automated. It is a Class III device, reviewed by the Pathology panel. Devices under MNM reach the market by PMA; FDA lists no cleared 510(k)s for it. 4 PMA applications cite this product code. FDA has posted 1 recall for MNM devices.
Classification
| Field | Value |
|---|---|
| Device name | Reader, Cervical Cytology Slide, Automated |
| Device class | Class III |
| Review panel | PA — Pathology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MNM devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-09-21.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code MNM?
MNM is the FDA product code for reader, cervical cytology slide, automated. It is a Class III device, reviewed by the Pathology panel.
What device class is MNM?
Class III. Typical premarket route: PMA.
Have MNM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-09-21.
Next steps
- Run an FDA pathway report with predicate devices for product code MNM
- Run a recall and safety report across every MNM manufacturer
- Watch product code MNM 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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