Sofia Lyme FIA, Sofia Lyme Control Set
K-Number: K163713 · 2017-10-20
ApplicantQuidel Corporation
Decision Date2017-10-20
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Sofia Lyme FIA, Sofia Lyme Control Set is a medical device manufactured by Quidel Corporation. It received FDA 510(k) clearance on 2017-10-20 under approval number K163713. 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 Lyme FIA, Sofia Lyme Control Set?
Sofia Lyme FIA, Sofia Lyme Control Set is a medical device that received FDA 510(k) clearance on 2017-10-20. It is manufactured by Quidel Corporation. The 510(k) number is K163713.
When was Sofia Lyme FIA, Sofia Lyme Control Set approved by the FDA?
Sofia Lyme FIA, Sofia Lyme Control Set received FDA 510(k) clearance on 2017-10-20, under approval number K163713.
What company makes Sofia Lyme FIA, Sofia Lyme Control Set?
Sofia Lyme FIA, Sofia Lyme Control Set is manufactured by Quidel Corporation.
What is the FDA product code for Sofia Lyme FIA, Sofia Lyme Control Set?
The FDA product code for Sofia 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.