The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Igg Subclass Single Dilution Diagnostic Kit For Use With The Beckman Array Analyzer.
| Device ID | K940422 |
| 510k Number | K940422 |
| Device Name: | IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER |
| Classification | Igg (gamma Chain Specific), Antigen, Antiserum, 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 | DFZ |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-19 |
| Decision Date | 1994-05-27 |