510(k) K062755
K062755 is an FDA 510(k) premarket notification submitted by Ikonisys, Inc. for the device "IKONISCOPE ONCOFISH BLADDER TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on January 4, 2007. The device falls under product code JOY (Device, Automated Cell-Locating), a Class II device regulated under 21 CFR 864.5260. Ikonisys, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 2007
- Date Received
- September 14, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Automated Cell-Locating
- Device Class
- Class II
- Regulation Number
- 864.5260
- Review Panel
- HE
- Submission Type