K915330 is an FDA 510(k) clearance for the DIRECTIGEN MENINGITIS COMBO TEST KIT. 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 (Franklin Lakes, US). The FDA issued a Cleared decision on March 23, 1992, 118 days after receiving the submission on November 26, 1991.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3390.
| 510(k) Number | K915330 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 1991 |
| Decision Date | March 23, 1992 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GTJ — Antisera, All Groups, N. Meningitidis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3390 |