K844407 is an FDA 510(k) clearance for the DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST. This device is classified as a Antisera, All Groups, N. Meningitidis (Class II - Special Controls, product code GTJ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on January 25, 1985, 73 days after receiving the submission on November 13, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3390.
| 510(k) Number | K844407 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 1984 |
| Decision Date | January 25, 1985 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GTJ — Antisera, All Groups, N. Meningitidis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3390 |