510(k) K801899
K801899 is an FDA 510(k) premarket notification submitted by Keithley Development Co. for the device "KEITHLEY LYMPHOCYTE DEPLETION CART". The FDA issued a decision of Substantially Equivalent on September 26, 1980. The device falls under product code KDK (Container, Transport, Kidney), a Class II device regulated under 21 CFR 876.5880. Keithley Development Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 1980
- Date Received
- August 8, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, Transport, Kidney
- Device Class
- Class II
- Regulation Number
- 876.5880
- Review Panel
- GU
- Submission Type