510(k) K760975
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 1977
- Date Received
- November 3, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oncometer, Plasma, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2720
- Review Panel
- CH
- Submission Type