K943686 is an FDA 510(k) clearance for the IL TEST BETA-2MICROGLOBULIN. This device is classified as a System, Test, Beta-2-microglobulin Immunological (Class II - Special Controls, product code JZG).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on May 15, 1995, 290 days after receiving the submission on July 29, 1994.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5630.
| 510(k) Number | K943686 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 1994 |
| Decision Date | May 15, 1995 |
| Days to Decision | 290 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JZG — System, Test, Beta-2-microglobulin Immunological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5630 |