K113190 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 24, 2012, 116 days after receiving the submission on October 31, 2011.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3300.
| 510(k) Number | K113190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2011 |
| Decision Date | February 24, 2012 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | MJH — Legionella, Spp., Elisa |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3300 |