The following data is part of a premarket notification filed by Ikonisys Inc with the FDA for Ikoniscope Oncofish Bladder Test System.
Device ID | K062755 |
510k Number | K062755 |
Device Name: | IKONISCOPE ONCOFISH BLADDER TEST SYSTEM |
Classification | Device, Automated Cell-locating |
Applicant | IKONISYS INC 5 SCIENCE PARK New Haven, CT 06511 |
Contact | Oscar Sanchez |
Correspondent | Oscar Sanchez IKONISYS INC 5 SCIENCE PARK New Haven, CT 06511 |
Product Code | JOY |
CFR Regulation Number | 864.5260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-09-14 |
Decision Date | 2007-01-04 |
Summary: | summary |