510(k) K030340
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 11, 2003
- Date Received
- January 31, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type