K770731 is an FDA 510(k) clearance for the EAGENT SYSTEM, CORTISOL, ARIA..
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on June 24, 1977, 65 days after receiving the submission on April 20, 1977.
This device falls under the Immunology FDA review panel.
| 510(k) Number | K770731 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 1977 |
| Decision Date | June 24, 1977 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | — |
| Device Class | — |