FDA product code CHC: Titrimetric Permanganate And Bromophenol Blue, Calcium
CHC is the FDA product code for titrimetric permanganate and bromophenol blue, calcium. It is a Class II device, regulated under 21 CFR 862.1145 and reviewed by the Clinical Chemistry panel. Devices under CHC reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Titrimetric Permanganate And Bromophenol Blue, Calcium |
| Device class | Class II |
| Regulation | 21 CFR 862.1145 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for CHC devices
openFDA lists no recalls for product code CHC.
Frequently asked questions
What is FDA product code CHC?
CHC is the FDA product code for titrimetric permanganate and bromophenol blue, calcium. It is a Class II device, regulated under 21 CFR 862.1145 and reviewed by the Clinical Chemistry panel.
What device class is CHC?
Class II, regulation 21 CFR 862.1145. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code CHC
- Run a recall and safety report across every CHC manufacturer
- Watch product code CHC 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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