K830646 is an FDA 510(k) clearance for the DIRECTIGEN NEISSERIA MENINGITIDIS..
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on May 27, 1983, 87 days after receiving the submission on March 1, 1983.
This device falls under the Microbiology FDA review panel.
| 510(k) Number | K830646 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 1983 |
| Decision Date | May 27, 1983 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | — |
| Device Class | — |