Product code MZU— Clinical Chemistry
DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B
- Classification name
- System, Test, Sodium, Enzymatic Method
- Device class
- Class 2
- Regulation
- 21 CFR 862.1665
- Advisory panel
- Clinical Chemistry
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code MZU
FDA has cleared devices under product code MZU between 2004 and 2008, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2008
- 2004
Top applicants under product code MZU
Recent clearances under product code MZU
Data sourced from openFDA. This site is unofficial and independent of the FDA.