K915431 is an FDA 510(k) clearance for the COMPLEMENT C1 INACTIVATOR KIT. This device is classified as a Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control (Class II - Special Controls, product code DBA).
Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on January 17, 1992, 46 days after receiving the submission on December 2, 1991.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5250.
| 510(k) Number | K915431 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 1991 |
| Decision Date | January 17, 1992 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DBA — Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5250 |