Data / Medical devices / System, Test, Sodium, Enzymatic Method
System, Test, Sodium, Enzymatic Method (MZU): 3 FDA-registered makers in 1 country
3 establishments in 1 country are registered with the FDA to make System, Test, Sodium, Enzymatic Method (product code MZU, Class 2, 21 CFR 862.1665). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on November 12, 2008, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MZU
- Device class
- 2
- Regulation
- 862.1665
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
Makers of System, Test, Sodium, Enzymatic Method
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bialex Lab | Wichita Falls, TX, United States | Manufacturer | 1 | October 7, 2004 | 0 | 0 | 0 | api.fda.gov |
| Diazyme Laboratories, Inc. | Poway, CA, United States | Manufacturer | 1 | November 12, 2008 | 0 | 0 | 0 | api.fda.gov |
| Infrared Laboratory Systems dba SYNERMED | Westfield, IN, United States | Manufacturer, Repackager or relabeler | 1 | November 12, 2008 | 0 | 0 | 0 | api.fda.gov |
Updated November 12, 2008. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.