The following data is part of a premarket notification filed by Quidel Corporation with the FDA for Sofia Lyme Fia, Sofia Lyme Control Set.
| Device ID | K163713 |
| 510k Number | K163713 |
| Device Name: | Sofia Lyme FIA, Sofia Lyme Control Set |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | Quidel Corporation 12544 High Bluff Drive, Suite 200 San Diego, CA 92130 |
| Contact | Jennifer S Rial |
| Correspondent | Jennifer S Rial Quidel Corporation 12544 High Bluff Drive, Suite 200 San Diego, CA 92130 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-30 |
| Decision Date | 2017-10-20 |
| Summary: | summary |