FDA product code MZU: System, Test, Sodium, Enzymatic Method
MZU is the FDA product code for system, test, sodium, enzymatic method. It is a Class II device, regulated under 21 CFR 862.1665 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under MZU. The average 510(k) review took 54 days (median 54).
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Sodium, Enzymatic Method |
| Device class | Class II |
| Regulation | 21 CFR 862.1665 |
| 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 MZU clearance
Top MZU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diazyme Laboratories | 2 | 2008-11-12 |
Most recent MZU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K082763 | Diazyme Laboratories | DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B | 2008-11-12 | 51 |
| K042189 | Diazyme Laboratories | DIAZYME SODIUM ENZYMATIC ASSAY | 2004-10-07 | 56 |
Recalls for MZU devices
openFDA lists no recalls for product code MZU.
Frequently asked questions
What is FDA product code MZU?
MZU is the FDA product code for system, test, sodium, enzymatic method. It is a Class II device, regulated under 21 CFR 862.1665 and reviewed by the Clinical Chemistry panel.
What device class is MZU?
Class II, regulation 21 CFR 862.1665. Typical premarket route: 510(k).
How long does a 510(k) take for product code MZU?
Across 2 cleared submissions the average was 54 days from receipt to decision (median 54).
Which companies have the most MZU clearances?
Diazyme Laboratories (2).
Next steps
- Run an FDA pathway report with predicate devices for product code MZU
- Run a recall and safety report across every MZU manufacturer
- Watch product code MZU 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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