The following data is part of a premarket notification filed by Bioclone Australia Pty Ltd. with the FDA for Bioclone's Elegance Hcg Elisa Kit.
| Device ID | K910420 |
| 510k Number | K910420 |
| Device Name: | BIOCLONE'S ELEGANCE HCG ELISA KIT |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| 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 | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-30 |
| Decision Date | 1991-02-26 |