510(k) K091455
DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL by
Diazyme Laboratories
— Product Code MZV
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 14, 2009
- Date Received
- May 18, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, System, Potassium, Enzymatic Method
- Device Class
- Class II
- Regulation Number
- 862.1600
- Review Panel
- CH
- Submission Type