Test, System, Potassium, Enzymatic Method
The Enzymatic Method Potassium Test System is a clinical chemistry in vitro diagnostic device that measures potassium concentration in blood, serum, or plasma using enzymatic methods, providing critical electrolyte data for patient management in conditions such as renal disease, cardiac arrhythmias, and electrolyte imbalances. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 862.1600 (Clinical Chemistry specialty). This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- MZV
- Device Class
- FDA class 2
- Regulation Number
- 862.1600
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K200865 | Piccolo Potassium Test System | Oct 20, 2021 | Substantially Equivalent | Abaxis, Inc. |
| K091455 | DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL | Aug 14, 2009 | Substantially Equivalent | Diazyme Laboratories |
| K053566 | MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A | Feb 15, 2006 | Substantially Equivalent | Diazyme Laboratories |
| K042191 | DIAZYME POTASSIUM ENZYMATIC ASSAY KIT | Oct 29, 2004 | Substantially Equivalent | Diazyme Laboratories |
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.