510(k) K033734
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 2003
- Date Received
- November 28, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Chemistry, Micro, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2170
- Review Panel
- CH
- Submission Type