K123182 is an FDA 510(k) clearance for the OSOM INFLUENZA A&B TEST MODEL 190. This device is classified as a Antigens, Cf (including Cf Control), Influenza Virus A, B, C (Class I - General Controls, product code GNX).
Submitted by SEKISUI Diagnostics, LLC (San Diego, US). The FDA issued a Cleared decision on November 5, 2012, 26 days after receiving the submission on October 10, 2012.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3330.
| 510(k) Number | K123182 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 2012 |
| Decision Date | November 05, 2012 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GNX - Antigens, Cf (including Cf Control), Influenza Virus A, B, C |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3330 |