The following data is part of a premarket notification filed by Bioclone Australia Pty Ltd. with the FDA for Bioclones Elegance Fsh Elisa Kit.
| Device ID | K904405 |
| 510k Number | K904405 |
| Device Name: | BIOCLONES ELEGANCE FSH ELISA KIT |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | BIOCLONE AUSTRALIA PTY LTD. C/O MACKLER & GIBBS, P.C. 1120 VERMONT AVE., NW, STE 600 Washington, DC 20005 |
| Contact | Bruce Mackler |
| Correspondent | Bruce Mackler BIOCLONE AUSTRALIA PTY LTD. C/O MACKLER & GIBBS, P.C. 1120 VERMONT AVE., NW, STE 600 Washington, DC 20005 |
| Product Code | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-25 |
| Decision Date | 1990-10-26 |