Sofia 2 Lyme FIA, Sofia Lyme Control Set
K-Number: K173496 · 2018-08-30
ApplicantQuidel Corporation
Decision Date2018-08-30
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Sofia 2 Lyme FIA, Sofia Lyme Control Set is a medical device manufactured by Quidel Corporation. It received FDA 510(k) clearance on 2018-08-30 under approval number K173496. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sofia 2 Lyme FIA, Sofia Lyme Control Set?
Sofia 2 Lyme FIA, Sofia Lyme Control Set is a medical device that received FDA 510(k) clearance on 2018-08-30. It is manufactured by Quidel Corporation. The 510(k) number is K173496.
When was Sofia 2 Lyme FIA, Sofia Lyme Control Set approved by the FDA?
Sofia 2 Lyme FIA, Sofia Lyme Control Set received FDA 510(k) clearance on 2018-08-30, under approval number K173496.
What company makes Sofia 2 Lyme FIA, Sofia Lyme Control Set?
Sofia 2 Lyme FIA, Sofia Lyme Control Set is manufactured by Quidel Corporation.
What is the FDA product code for Sofia 2 Lyme FIA, Sofia Lyme Control Set?
The FDA product code for Sofia 2 Lyme FIA, Sofia Lyme Control Set is LSR.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.