510(k) K964375
K964375 is an FDA 510(k) premarket notification submitted by Sysmex Corp. for the device "SYSMEX SE/RAM-1". The FDA issued a decision of Substantially Equivalent on March 13, 1997. 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
- March 13, 1997
- Date Received
- November 1, 1996
- 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