FDA product code MZV: Test, System, Potassium, Enzymatic Method
MZV is the FDA product code for test, system, potassium, enzymatic method. It is a Class II device, regulated under 21 CFR 862.1600 and reviewed by the Clinical Chemistry panel. FDA has cleared 4 510(k) submissions under MZV, from 2 different applicants. The average 510(k) review took 197 days (median 83).
Classification
| Field | Value |
|---|---|
| Device name | Test, System, Potassium, Enzymatic Method |
| Device class | Class II |
| Regulation | 21 CFR 862.1600 |
| 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 MZV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 567 |
Compare with all 510(k) review times · Search every MZV clearance
Top MZV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diazyme Laboratories | 3 | 2009-08-14 |
| Abaxis, Inc. | 1 | 2021-10-20 |
Most recent MZV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K200865 | Abaxis, Inc. | Piccolo Potassium Test System | 2021-10-20 | 567 |
| K091455 | Diazyme Laboratories | DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL | 2009-08-14 | 88 |
| K053566 | Diazyme Laboratories | MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A | 2006-02-15 | 55 |
| K042191 | Diazyme Laboratories | DIAZYME POTASSIUM ENZYMATIC ASSAY KIT | 2004-10-29 | 78 |
Recalls for MZV devices
openFDA lists no recalls for product code MZV.
Frequently asked questions
What is FDA product code MZV?
MZV is the FDA product code for test, system, potassium, enzymatic method. It is a Class II device, regulated under 21 CFR 862.1600 and reviewed by the Clinical Chemistry panel.
What device class is MZV?
Class II, regulation 21 CFR 862.1600. Typical premarket route: 510(k).
How long does a 510(k) take for product code MZV?
Across 4 cleared submissions the average was 197 days from receipt to decision (median 83).
Which companies have the most MZV clearances?
Diazyme Laboratories (3); Abaxis, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MZV
- Run a recall and safety report across every MZV manufacturer
- Watch product code MZV 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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