510(k) K790026
K790026 is an FDA 510(k) premarket notification submitted by Sysmex Corp. for the device "ANALYZER, MODEL CC-720". The FDA issued a decision of Substantially Equivalent on February 8, 1979. The device falls under product code GKL (Counter, Cell, Automated (Particle Counter)), a Class II device regulated under 21 CFR 864.5200. Sysmex Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 1979
- Date Received
- January 3, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Counter, Cell, Automated (Particle Counter)
- Device Class
- Class II
- Regulation Number
- 864.5200
- Review Panel
- HE
- Submission Type