510(k) K032677
K032677 is an FDA 510(k) premarket notification submitted by Sysmex America, Inc. for the device "SYSMEX POCH-100I". The FDA issued a decision of Substantially Equivalent on February 11, 2004. The device falls under product code GKL (Counter, Cell, Automated (Particle Counter)), a Class II device regulated under 21 CFR 864.5200. Sysmex America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 11, 2004
- Date Received
- August 29, 2003
- 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