510(k) K801385
K801385 is an FDA 510(k) premarket notification submitted by Organon Teknika Corp. for the device "K1 POTASSIUM ACETATE ADDITIVE". The FDA issued a decision of Substantially Equivalent on Jul 21, 1980. The device falls under product code FKT (System, Dialysate Delivery, Sorbent Regenerated), a Class II device regulated under 21 CFR 876.5600. Organon Teknika Corp. has 129 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 21, 1980
- Date Received
- Jun 13, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Dialysate Delivery, Sorbent Regenerated
- Device Class
- Class II
- Regulation Number
- 876.5600
- Review Panel
- GU
- Submission Type
- 510(k)