The following data is part of a premarket notification filed by Ikonisys Inc with the FDA for Ikoniscope Fastfish Auto/amniocyte Test System.
| Device ID | K061392 |
| 510k Number | K061392 |
| Device Name: | IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM |
| Classification | Device, Automated Cell-locating |
| Applicant | IKONISYS INC 5 SCIENCE PARK New Haven, CT 06511 |
| Contact | S. Michael Sharp |
| Correspondent | S. Michael Sharp 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 | 2006-05-19 |
| Decision Date | 2006-08-01 |
| Summary: | summary |