K150412 is an FDA 510(k) clearance for the Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator. This device is classified as a Complement C9, Antigen, Antiserum, Control (Class II - Special Controls, product code DAE).
Submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on August 28, 2015, 191 days after receiving the submission on February 18, 2015.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5240.
| 510(k) Number | K150412 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2015 |
| Decision Date | August 28, 2015 |
| Days to Decision | 191 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DAE — Complement C9, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5240 |