The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Total Haemolytic Complement Rid Kit.
| Device ID | K992488 |
| 510k Number | K992488 |
| Device Name: | TOTAL HAEMOLYTIC COMPLEMENT RID KIT |
| Classification | Complement C9, 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 | DAE |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-26 |
| Decision Date | 1999-09-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700010283 | K992488 | 000 |
| 05051700010276 | K992488 | 000 |
| 05051700010269 | K992488 | 000 |