The following data is part of a premarket notification filed by Bioclone Australia Pty Ltd. with the FDA for Elegance Tsh Elisa.
| Device ID | K905099 |
| 510k Number | K905099 |
| Device Name: | ELEGANCE TSH ELISA |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | BIOCLONE AUSTRALIA PTY LTD. C/O MACKLER & GIBBS, P.C. 1120 VERMONT AVE., NW, STE 600 Washington, DC 20005 |
| Contact | Micha Barach |
| Correspondent | Micha Barach BIOCLONE AUSTRALIA PTY LTD. C/O MACKLER & GIBBS, P.C. 1120 VERMONT AVE., NW, STE 600 Washington, DC 20005 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-13 |
| Decision Date | 1990-12-18 |