K952791 is an FDA 510(k) clearance for the DIRECTIGEN MENINGITIS COMBO 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 (Cockeysville, US). The FDA issued a Cleared decision on May 30, 1996, 346 days after receiving the submission on June 19, 1995.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3390.
| 510(k) Number | K952791 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 1995 |
| Decision Date | May 30, 1996 |
| Days to Decision | 346 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 |