K083289 is an FDA 510(k) clearance for the HUMAN BETA-2 MICROGLOBULIN 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. (Santa Monica, US). The FDA issued a Cleared decision on May 6, 2009, 180 days after receiving the submission on November 7, 2008.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5630.
| 510(k) Number | K083289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 2008 |
| Decision Date | May 06, 2009 |
| Days to Decision | 180 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 |