510(k) K790282
K790282 is an FDA 510(k) premarket notification submitted by Nordisk Infuser System for the device "ELDONCARD". The FDA issued a decision of Substantially Equivalent on May 4, 1979. The device falls under product code KSZ (System, Test, Automated Blood Grouping And Antibody), a Class II device regulated under 21 CFR 864.9175. Nordisk Infuser System has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 1979
- Date Received
- February 13, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Automated Blood Grouping And Antibody
- Device Class
- Class II
- Regulation Number
- 864.9175
- Review Panel
- HE
- Submission Type