510(k) K895844
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 24, 1989
- Date Received
- October 3, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Coagulation, Automated
- Device Class
- Class II
- Regulation Number
- 864.5400
- Review Panel
- HE
- Submission Type