510(k) K910222
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 1991
- Date Received
- January 18, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Chemistry, Centrifugal, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2140
- Review Panel
- CH
- Submission Type