510(k) K926409
K926409 is an FDA 510(k) premarket notification submitted by Apheresis Technologies, Inc. for the device "PLASMA DISCARD BAGS". The FDA issued a decision of Substantially Equivalent on March 2, 1993. The device falls under product code LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic), a Class U device. Apheresis Technologies, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 1993
- Date Received
- December 21, 1992
- 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