K913131 is an FDA 510(k) clearance for the HUMAN BETA-2 MICROGLOBIN EN-RID KIT. This device is classified as a System, Test, Beta-2-microglobulin Immunological (Class II - Special Controls, product code JZG).
Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on November 7, 1991, 114 days after receiving the submission on July 16, 1991.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5630.
| 510(k) Number | K913131 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 1991 |
| Decision Date | November 07, 1991 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | JZG — System, Test, Beta-2-microglobulin Immunological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5630 |