The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Human Igg Subclass Kit Use With The Beckman Image Analyzer.
| Device ID | K000701 |
| 510k Number | K000701 |
| Device Name: | HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER |
| Classification | Method, Nephelometric, Immunoglobulins (g, A, M) |
| Applicant | THE BINDING SITE, LTD. WEST TOWER, SUITE 4000 2425 WEST OLYMPIC BOULEVARD Santa Monica, CA 90404 |
| Contact | Jay H Geller |
| Correspondent | Jay H Geller THE BINDING SITE, LTD. WEST TOWER, SUITE 4000 2425 WEST OLYMPIC BOULEVARD 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 | 2000-03-01 |
| Decision Date | 2000-04-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700007702 | K000701 | 000 |
| 05051700007603 | K000701 | 000 |
| 05051700006224 | K000701 | 000 |