The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Minineph Human B2-microglobulin Kit.
| Device ID | K014270 |
| 510k Number | K014270 |
| Device Name: | MININEPH HUMAN B2-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 | 2001-12-27 |
| Decision Date | 2002-08-15 |