K153560 is an FDA 510(k) clearance for the Optilite Low Level Albumin Kit. This device is classified as a Albumin, Antigen, Antiserum, Control (Class II - Special Controls, product code DCF).
Submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on August 25, 2016, 255 days after receiving the submission on December 14, 2015.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5040.
| 510(k) Number | K153560 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 2015 |
| Decision Date | August 25, 2016 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DCF — Albumin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5040 |