The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Bindazyme Anti-dsdna Eia Kit.
Device ID | K993727 |
510k Number | K993727 |
Device Name: | BINDAZYME ANTI-DSDNA EIA KIT |
Classification | Anti-dna Antibody (enzyme-labeled), Antigen, Control |
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 | LRM |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-10-25 |
Decision Date | 1999-12-21 |