K914389 is an FDA 510(k) clearance for the ALPHA-2 MACROGLOBULIN TEST RID KIT. This device is classified as a Alpha-2-macroglobulin, Antigen, Antiserum, Control (Class II - Special Controls, product code DEB).
Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on December 20, 1991, 80 days after receiving the submission on October 1, 1991.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5620.
| 510(k) Number | K914389 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 1991 |
| Decision Date | December 20, 1991 |
| Days to Decision | 80 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 |