510(k) K042191
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 2004
- Date Received
- August 12, 2004
- 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