The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Freelite Human Kappa And Lambda Free Kits For Use On The Olympus Au Analyzer.
| Device ID | K033811 |
| 510k Number | K033811 |
| Device Name: | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER |
| Classification | Lambda, Antigen, Antiserum, Control |
| Applicant | THE BINDING SITE, LTD. WEST TOWER, SUITE 4000 2425 WEST OLYMPIC BOULEVARD Santa Monica, CA 90404 |
| Contact | Jay H Geller |
| Correspondent | Jay H Geller THE BINDING SITE, LTD. WEST TOWER, SUITE 4000 2425 WEST OLYMPIC BOULEVARD Santa Monica, CA 90404 |
| Product Code | DEH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-09 |
| Decision Date | 2004-01-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700006408 | K033811 | 000 |
| 05051700006286 | K033811 | 000 |