K122066 is an FDA 510(k) clearance for the HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS. This device is classified as a System, Test, Beta-2-microglobulin Immunological (Class II - Special Controls, product code JZG).
Submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on August 30, 2012, 45 days after receiving the submission on July 16, 2012.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5630.
| 510(k) Number | K122066 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2012 |
| Decision Date | August 30, 2012 |
| Days to Decision | 45 days |
| Submission Type | Special |
| 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 |