510(k) K902445
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 1990
- Date Received
- June 1, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lymphocyte Separation Medium
- Device Class
- Class I
- Regulation Number
- 864.8500
- Review Panel
- HE
- Submission Type