K981785 is an FDA 510(k) clearance for the C4 MININEPH ANTISERUM. This device is classified as a Complement C4, Antigen, Antiserum, Control (Class II - Special Controls, product code DBI).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on December 20, 1999, 579 days after receiving the submission on May 20, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5240.
| 510(k) Number | K981785 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 1998 |
| Decision Date | December 20, 1999 |
| Days to Decision | 579 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DBI — Complement C4, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5240 |