510(k) K830831
K830831 is an FDA 510(k) premarket notification submitted by Cryosan, Inc. for the device "AUTOMATED BLOOD CELL SEPARATOR". The FDA issued a decision of Substantially Equivalent on June 16, 1983. The device falls under product code LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic), a Class U device. Cryosan, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 16, 1983
- Date Received
- March 16, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Separator, Automated, Blood Cell And Plasma, Therapeutic
- Device Class
- Class U
- Regulation Number
- Review Panel
- GU
- Submission Type