System, Test, Sodium, Enzymatic Method
The Enzymatic Method Sodium Test System is a clinical chemistry in vitro diagnostic device that measures sodium concentration in blood, serum, plasma, or urine using enzymatic reaction methods, providing accurate electrolyte analysis for patient management. Sodium measurement is essential for evaluating fluid and electrolyte balance. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 862.1665 (Clinical Chemistry specialty). This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- MZU
- Device Class
- FDA class 2
- Regulation Number
- 862.1665
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.