K163273 is an FDA 510(k) clearance for the TRU Legionella. This device is classified as a Legionella, Spp., Elisa (Class II - Special Controls, product code MJH).
Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on February 21, 2017, 92 days after receiving the submission on November 21, 2016.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3300.
| 510(k) Number | K163273 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2016 |
| Decision Date | February 21, 2017 |
| Days to Decision | 92 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | MJH — Legionella, Spp., Elisa |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3300 |