K980724 is an FDA 510(k) clearance for the TINAQUANT B 2-MICROGLOBULIN ASSAY. This device is classified as a System, Test, Beta-2-microglobulin Immunological (Class II - Special Controls, product code JZG).
Submitted by Boehringer Mannheim Corp. (Pleasanton, US). The FDA issued a Cleared decision on October 16, 1998, 234 days after receiving the submission on February 24, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5630.
| 510(k) Number | K980724 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 1998 |
| Decision Date | October 16, 1998 |
| Days to Decision | 234 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 |