The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Bindazyme Anti-pr3 Enzyme Immunoassay Kit.
| Device ID | K981029 |
| 510k Number | K981029 |
| Device Name: | BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| 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 | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-19 |
| Decision Date | 1998-07-20 |