The following data is part of a premarket notification filed by Quidel Corporation with the FDA for Solana Trichomonas Assay.
| Device ID | K161182 |
| 510k Number | K161182 |
| Device Name: | Solana Trichomonas Assay |
| Classification | Trichomonas Vaginalis Nucleic Acid Amplification Test System |
| Applicant | QUIDEL CORPORATION 2005 EAST STATE STREET, SUITE 100 Athens, OH 45701 |
| Contact | Ronald H Lollar |
| Correspondent | Ronald H Lollar QUIDEL CORPORATION 2005 EAST STATE STREET, SUITE 100 Athens, OH 45701 |
| Product Code | OUY |
| CFR Regulation Number | 866.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-27 |
| Decision Date | 2016-08-15 |
| Summary: | summary |