The following data is part of a premarket notification filed by The Binding Site with the FDA for Binding Site Igg Sublcass Olympus Kits.
| Device ID | K042152 |
| 510k Number | K042152 |
| Device Name: | BINDING SITE IGG SUBLCASS OLYMPUS KITS |
| Classification | Method, Nephelometric, Immunoglobulins (g, A, M) |
| 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 | CFN |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-09 |
| Decision Date | 2004-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700007658 | K042152 | 000 |
| 05051700007566 | K042152 | 000 |
| 05051700006187 | K042152 | 000 |
| 05051700006118 | K042152 | 000 |