FDA product code CHW: Titrimetric With Edta And Indicator, Calcium
CHW is the FDA product code for titrimetric with edta and indicator, calcium. It is a Class II device, regulated under 21 CFR 862.1145 and reviewed by the Clinical Chemistry panel. FDA has cleared 3 510(k) submissions under CHW, from 3 different applicants. The average 510(k) review took 179 days (median 161).
Classification
| Field | Value |
|---|---|
| Device name | Titrimetric With Edta And Indicator, 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 |
510(k) clearances per year for CHW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 348 |
Compare with all 510(k) review times · Search every CHW clearance
Top CHW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biosystems S.A. | 1 | 2020-09-09 |
| Roche Diagnostics | 1 | 2012-05-08 |
| Union Carbide Corp. | 1 | 1978-09-20 |
Most recent CHW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192730 | Biosystems S.A. | CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV | 2020-09-09 | 348 |
| K113521 | Roche Diagnostics | CALCIUM GEN. 2 | 2012-05-08 | 161 |
| K781454 | Union Carbide Corp. | LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA | 1978-09-20 | 29 |
Recalls for CHW devices
openFDA lists no recalls for product code CHW.
Frequently asked questions
What is FDA product code CHW?
CHW is the FDA product code for titrimetric with edta and indicator, calcium. It is a Class II device, regulated under 21 CFR 862.1145 and reviewed by the Clinical Chemistry panel.
What device class is CHW?
Class II, regulation 21 CFR 862.1145. Typical premarket route: 510(k).
How long does a 510(k) take for product code CHW?
Across 3 cleared submissions the average was 179 days from receipt to decision (median 161).
Which companies have the most CHW clearances?
Biosystems S.A. (1); Roche Diagnostics (1); Union Carbide Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CHW
- Run a recall and safety report across every CHW manufacturer
- Watch product code CHW 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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