K792588 is an FDA 510(k) clearance for the TERRITIN RIA KIT. This device is classified as a Radioimmunoassay (two-site Solid Phase), Ferritin (Class II - Special Controls, product code JMG).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on January 11, 1980, 25 days after receiving the submission on December 17, 1979.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5340.
| 510(k) Number | K792588 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 1979 |
| Decision Date | January 11, 1980 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JMG — Radioimmunoassay (two-site Solid Phase), Ferritin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5340 |