510(k) K854076
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 1985
- Date Received
- October 7, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mass Spectrometer, Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2860
- Review Panel
- TX
- Submission Type