510(k) K022774
K022774 is an FDA 510(k) premarket notification submitted by Intl. Remote Imaging Systems for the device "IQ 200 SYSTEM". The FDA issued a decision of Substantially Equivalent on Oct 21, 2002. The device falls under product code LKM (Counter, Urine Particle), a Class II device regulated under 21 CFR 864.5200. Intl. Remote Imaging Systems has 13 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 21, 2002
- Date Received
- Aug 21, 2002
- 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
- 510(k)