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 Diagnostic Test Kits For Use On The Roche Cobas Integra 400/400 Plus Analyzer Kit.
| Device ID | K070900 |
| 510k Number | K070900 |
| Device Name: | FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT |
| Classification | Kappa, Antigen, Antiserum, Control |
| Applicant | THE BINDING SITE, LTD. EAST TOWER, SUITE 600 2425 WEST OLYMPIC BOULEVARD Santa Monica, CA 90404 |
| Contact | Jay H Geller |
| Correspondent | Jay H Geller THE BINDING SITE, LTD. EAST TOWER, SUITE 600 2425 WEST OLYMPIC BOULEVARD Santa Monica, CA 90404 |
| Product Code | DFH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-02 |
| Decision Date | 2007-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700012355 | K070900 | 000 |
| 05051700006460 | K070900 | 000 |
| 05051700006347 | K070900 | 000 |