510(k) K093861
K093861 is an FDA 510(k) premarket notification submitted by Iris International, Inc. for the device "IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE". The FDA issued a decision of Substantially Equivalent on February 5, 2010. The device falls under product code LKM (Counter, Urine Particle), a Class II device regulated under 21 CFR 864.5200. Iris International, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 2010
- Date Received
- December 16, 2009
- Clearance Type
- Special
- 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