510(k) K173691
K173691 is an FDA 510(k) premarket notification submitted by Quidel Corporation for the device "Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack". The FDA issued a decision of Substantially Equivalent on February 28, 2018. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Quidel Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 2018
- Date Received
- December 1, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reagent, Borrelia Serological Reagent
- Device Class
- Class II
- Regulation Number
- 866.3830
- Review Panel
- MI
- Submission Type