The following data is part of a premarket notification filed by The Binding Site Group, Ltd. with the FDA for Freelite Human Lambda Free Kit.
| Device ID | K140396 |
| 510k Number | K140396 |
| Device Name: | FREELITE HUMAN LAMBDA FREE KIT |
| Classification | Lambda, Antigen, Antiserum, Control |
| Applicant | THE BINDING SITE GROUP, LTD. 5889 OBDERLIN DR., STE 101 San Diego, CA 92121 |
| Contact | Doug Kurth |
| Correspondent | Doug Kurth THE BINDING SITE GROUP, LTD. 5889 OBDERLIN DR., STE 101 San Diego, CA 92121 |
| Product Code | DEH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-18 |
| Decision Date | 2014-04-16 |