The following data is part of a premarket notification filed by The Binding Site with the FDA for Bindazyme Human Anti Tissue Transglutaminase Iga And Igg Eia Diagnostic Test Kits.
| Device ID | K040466 |
| 510k Number | K040466 |
| Device Name: | BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| Applicant | THE BINDING SITE WEST TOWER, SUITE 4000 2425 WEST OLYMPIC BLVD. Santa Monica, CA 90404 |
| Contact | Jay H Geller |
| Correspondent | Jay H Geller THE BINDING SITE WEST TOWER, SUITE 4000 2425 WEST OLYMPIC BLVD. Santa Monica, CA 90404 |
| Product Code | MVM |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-23 |
| Decision Date | 2004-07-16 |