510(k) K823697
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 5, 1983
- Date Received
- December 9, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ion-Exchange Chromatography
- Device Class
- Class I
- Regulation Number
- 862.2230
- Review Panel
- TX
- Submission Type