MZV — Test, System, Potassium, Enzymatic Method Class II
FDA product code MZV covers "Test, System, Potassium, Enzymatic Method", a Class II medical device regulated under 21 CFR 862.1600. Submissions are reviewed by the Clinical Chemistry panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MZV
- Device Class
- Class II
- Regulation Number
- 862.1600
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K200865 | abaxis | Piccolo Potassium Test System | October 20, 2021 |
| K091455 | diazyme laboratories | DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQ | August 14, 2009 |
| K053566 | diazyme laboratories | MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A | February 15, 2006 |
| K042191 | diazyme laboratories | DIAZYME POTASSIUM ENZYMATIC ASSAY KIT | October 29, 2004 |