K890421 is an FDA 510(k) clearance for the IMX B2-MICROGLOBULIN. This device is classified as a System, Test, Beta-2-microglobulin Immunological (Class II - Special Controls, product code JZG).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 9, 1989, 42 days after receiving the submission on January 26, 1989.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5630.
| 510(k) Number | K890421 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 1989 |
| Decision Date | March 09, 1989 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JZG — System, Test, Beta-2-microglobulin Immunological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5630 |