510(k) K813564
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 1982
- Date Received
- December 22, 1981
- 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