K141100 is an FDA 510(k) clearance for the OPTILITE 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 Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on July 18, 2014, 80 days after receiving the submission on April 29, 2014.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5250.
| 510(k) Number | K141100 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 2014 |
| Decision Date | July 18, 2014 |
| Days to Decision | 80 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 |