FDA product code CGZ: Electrode, Ion-Specific, Chloride
CGZ is the FDA product code for electrode, ion-specific, chloride. It is a Class II device, regulated under 21 CFR 862.1170 and reviewed by the Clinical Chemistry panel. FDA has cleared 38 510(k) submissions under CGZ, from 25 different applicants. The average 510(k) review took 103 days (median 60). FDA has posted 11 recalls for CGZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Ion-Specific, 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 |
510(k) clearances per year for CGZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 265 |
| 2018 | 1 | 90 |
Compare with all 510(k) review times · Search every CGZ clearance
Top CGZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wallac OY | 4 | 2008-04-14 |
| Abbott Laboratories | 3 | 2017-10-24 |
| Hichem Diagnostics | 3 | 1995-09-06 |
| Ortho-Clinical Diagnostics, Inc. | 2 | 2018-10-30 |
| Phoenix Diagnostics, Inc. | 2 | 2002-02-04 |
20 more applicants have CGZ clearances. See the full list in Caduvo.
Most recent CGZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K182072 | Ortho-Clinical Diagnostics, Inc. | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides | 2018-10-30 | 90 |
| K170320 | Abbott Laboratories | Alinity c ICT Sample Diluent | 2017-10-24 | 265 |
| K162020 | Ortho Clinical Diagnostics | VITROS Chemistry Products Cl- Slides | 2016-12-16 | 148 |
| K082099 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905 | 2008-08-21 | 27 |
| K070889 | Wallac OY | AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 | 2008-04-14 | 381 |
Recalls for CGZ devices
11 product recalls in 10 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-09-10.
| Year | Recalls |
|---|---|
| 2018 | 3 |
| 2019 | 2 |
Frequently asked questions
What is FDA product code CGZ?
CGZ is the FDA product code for electrode, ion-specific, chloride. It is a Class II device, regulated under 21 CFR 862.1170 and reviewed by the Clinical Chemistry panel.
What device class is CGZ?
Class II, regulation 21 CFR 862.1170. Typical premarket route: 510(k).
How long does a 510(k) take for product code CGZ?
Across 38 cleared submissions the average was 103 days from receipt to decision (median 60).
Which companies have the most CGZ clearances?
Wallac OY (4); Abbott Laboratories (3); Hichem Diagnostics (3); Ortho-Clinical Diagnostics, Inc. (2); Phoenix Diagnostics, Inc. (2).
Have CGZ devices been recalled?
Yes: 11 product recalls across 10 recall events; the most recent began 2019-09-10.
Next steps
- Run an FDA pathway report with predicate devices for product code CGZ
- Run a recall and safety report across every CGZ manufacturer
- Watch product code CGZ 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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