K841308 is an FDA 510(k) clearance for the DIRECTIGEN MENNINGITIS TEST KIT. This device is classified as a Antisera, Fluorescent, All Groups, N. Meningitidis (Class II - Special Controls, product code GTI).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on May 2, 1984, 33 days after receiving the submission on March 30, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3390.
| 510(k) Number | K841308 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 1984 |
| Decision Date | May 02, 1984 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GTI — Antisera, Fluorescent, All Groups, N. Meningitidis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3390 |