510(k) K974290
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 1997
- Date Received
- November 14, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator, Multi-Analyte Mixture
- Device Class
- Class II
- Regulation Number
- 862.1150
- Review Panel
- CH
- Submission Type