K143118 is an FDA 510(k) clearance for the Human Microalbumin kit for use on SPAPLUS. 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 May 26, 2015, 208 days after receiving the submission on October 30, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5040.
| 510(k) Number | K143118 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2014 |
| Decision Date | May 26, 2015 |
| Days to Decision | 208 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | DCF — Albumin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5040 |