MZV
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Test, System, Potassium, Enzymatic Method
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1600
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2009: 8 · 2010: 8 · 2011: 57 · 2012: 32 · 2013: 63 · 2014: 22
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Piccolo Potassium Test System (K200865) | Abaxis, Inc. | 2021-10-20 |
| DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL (K091455) | Diazyme Laboratories | 2009-08-14 |
| MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A (K053566) | Diazyme Laboratories | 2006-02-15 |
| DIAZYME POTASSIUM ENZYMATIC ASSAY KIT (K042191) | Diazyme Laboratories | 2004-10-29 |
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Every clearance here is in the API, with alerts when new ones post.