The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Human Beta-2 Microglobulin Kit.
| Device ID | K083289 |
| 510k Number | K083289 |
| Device Name: | HUMAN BETA-2 MICROGLOBULIN KIT |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| 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 | JZG |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-07 |
| Decision Date | 2009-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700017619 | K083289 | 000 |
| 05051700012157 | K083289 | 000 |