K821266 is an FDA 510(k) clearance for the BBL DIRECTIGEN MENINGITIS TEST KIT. This device is classified as a Antisera, All Types, H. Influenza (Class II - Special Controls, product code GRP).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on June 1, 1982, 29 days after receiving the submission on May 3, 1982.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3300.
| 510(k) Number | K821266 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 1982 |
| Decision Date | June 01, 1982 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GRP — Antisera, All Types, H. Influenza |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3300 |