K140664 is an FDA 510(k) clearance for the HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS. This device is classified as a Alpha-2-macroglobulin, Antigen, Antiserum, Control (Class II - Special Controls, product code DEB).
Submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on April 16, 2014, 29 days after receiving the submission on March 18, 2014.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5620.
| 510(k) Number | K140664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 2014 |
| Decision Date | April 16, 2014 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DEB — Alpha-2-macroglobulin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5620 |