510(k) K012372
K012372 is an FDA 510(k) premarket notification submitted by Sysmex Corp. for the device "SYSMEX UF-50". The FDA issued a decision of Substantially Equivalent on September 28, 2001. The device falls under product code LKM (Counter, Urine Particle), 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
- September 28, 2001
- Date Received
- July 26, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Counter, Urine Particle
- Device Class
- Class II
- Regulation Number
- 864.5200
- Review Panel
- HE
- Submission Type