K181436 is an FDA 510(k) clearance for the OSOM Mono Test. This device is classified as a System, Test, Infectious Mononucleosis (Class II - Special Controls, product code KTN).
Submitted by SEKISUI Diagnostics, LLC (San Diego, US). The FDA issued a Cleared decision on June 22, 2018, 21 days after receiving the submission on June 1, 2018.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.5640.
| 510(k) Number | K181436 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2018 |
| Decision Date | June 22, 2018 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | KTN - System, Test, Infectious Mononucleosis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5640 |