The following data is part of a premarket notification filed by Bioclone Australia Pty Ltd. with the FDA for Elegance Neonatal Tsh Elisa.
| Device ID | K935049 |
| 510k Number | K935049 |
| Device Name: | ELEGANCE NEONATAL TSH ELISA |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | BIOCLONE AUSTRALIA PTY LTD. 1920 N STREET, N.W. SUITE 650 Washington, DC 20036 |
| Contact | Bruce F Mackler |
| Correspondent | Bruce F Mackler BIOCLONE AUSTRALIA PTY LTD. 1920 N STREET, N.W. SUITE 650 Washington, DC 20036 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-20 |
| Decision Date | 1994-10-03 |