510(k) K883585
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 1988
- Date Received
- August 23, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tetraphenyl Borate, Colorimetry, Potassium
- Device Class
- Class II
- Regulation Number
- 862.1600
- Review Panel
- CH
- Submission Type