510(k) K013278
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 2001
- Date Received
- October 1, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lipoprotein X, Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.5590
- Review Panel
- IM
- Submission Type