FDA product code CHR: Titrimetric Phenol Red, Carbon-Dioxide
CHR is the FDA product code for titrimetric phenol red, carbon-dioxide. It is a Class II device, regulated under 21 CFR 862.1160 and reviewed by the Clinical Chemistry panel. Devices under CHR reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Titrimetric Phenol Red, Carbon-Dioxide |
| Device class | Class II |
| Regulation | 21 CFR 862.1160 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for CHR devices
openFDA lists no recalls for product code CHR.
Frequently asked questions
What is FDA product code CHR?
CHR is the FDA product code for titrimetric phenol red, carbon-dioxide. It is a Class II device, regulated under 21 CFR 862.1160 and reviewed by the Clinical Chemistry panel.
What device class is CHR?
Class II, regulation 21 CFR 862.1160. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code CHR
- Run a recall and safety report across every CHR manufacturer
- Watch product code CHR 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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