FDA product code CHK: Mercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride
CHK is the FDA product code for mercuric nitrate and diphenyl carbazone (titrimetric), chloride. It is a Class II device, regulated under 21 CFR 862.1170 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under CHK. The average 510(k) review took 160 days (median 160).
Classification
| Field | Value |
|---|---|
| Device name | Mercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride |
| Device class | Class II |
| Regulation | 21 CFR 862.1170 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every CHK clearance
Top CHK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Miles Laboratories, Inc. | 1 | 1987-06-29 |
Most recent CHK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K870214 | Miles Laboratories, Inc. | MODIFIED SALTEX REAGENT STRIPS | 1987-06-29 | 160 |
Recalls for CHK devices
openFDA lists no recalls for product code CHK.
Frequently asked questions
What is FDA product code CHK?
CHK is the FDA product code for mercuric nitrate and diphenyl carbazone (titrimetric), chloride. It is a Class II device, regulated under 21 CFR 862.1170 and reviewed by the Clinical Chemistry panel.
What device class is CHK?
Class II, regulation 21 CFR 862.1170. Typical premarket route: 510(k).
How long does a 510(k) take for product code CHK?
Across 1 cleared submissions the average was 160 days from receipt to decision (median 160).
Which companies have the most CHK clearances?
Miles Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CHK
- Run a recall and safety report across every CHK manufacturer
- Watch product code CHK 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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