K191184 is an FDA 510(k) clearance for the ImmuView S pneumoniae and L pneumophila Urinary Antigen Test. This device is classified as a Legionella, Spp., Elisa (Class II - Special Controls, product code MJH).
Submitted by Ssi Diagnostica A/S (Hilleroed, DK). The FDA issued a Cleared decision on March 5, 2020, 307 days after receiving the submission on May 3, 2019.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3300.
| 510(k) Number | K191184 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2019 |
| Decision Date | March 05, 2020 |
| Days to Decision | 307 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 |