The following data is part of a premarket notification filed by Quidel Corporation with the FDA for Sofia Lyme Fia, Sofia 2 Analyzer, Sofia 2 Installation Pack.
Device ID | K173691 |
510k Number | K173691 |
Device Name: | Sofia Lyme FIA, Sofia 2 Analyzer, Sofia 2 Installation Pack |
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 | 2017-12-01 |
Decision Date | 2018-02-28 |
Summary: | summary |