510(k) K970616
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1997
- Date Received
- February 18, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Station, Pipetting And Diluting, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2750
- Review Panel
- CH
- Submission Type