The following data is part of a premarket notification filed by Quidel Corporation with the FDA for Solana C. Difficile Assay.
| Device ID | K170491 |
| 510k Number | K170491 |
| Device Name: | Solana C. Difficile Assay |
| Classification | C. Difficile Toxin Gene Amplification Assay |
| 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 | OZN |
| CFR Regulation Number | 866.3130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-17 |
| Decision Date | 2017-05-11 |
| Summary: | summary |