The following data is part of a premarket notification filed by Bioclone Australia Pty Ltd. with the FDA for Elegance Ft4 Elisa.
| Device ID | K922284 |
| 510k Number | K922284 |
| Device Name: | ELEGANCE FT4 ELISA |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | BIOCLONE AUSTRALIA PTY LTD. C/O BAKER & HOSTETLER 1050 CONNECTICUT AVE., N.W., Ste 1100, Washington, DC 20036 |
| Contact | Bruce F Mackler |
| Correspondent | Bruce F Mackler BIOCLONE AUSTRALIA PTY LTD. C/O BAKER & HOSTETLER 1050 CONNECTICUT AVE., N.W., Ste 1100, Washington, DC 20036 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-15 |
| Decision Date | 1992-07-10 |