K122304 is an FDA 510(k) clearance for the HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS. 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 Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on April 15, 2013, 257 days after receiving the submission on August 1, 2012.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5250.
| 510(k) Number | K122304 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2012 |
| Decision Date | April 15, 2013 |
| Days to Decision | 257 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 |