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FDA 510(k)

Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack

K-Number: K173691 · 2018-02-28

ApplicantQuidel Corporation
Decision Date2018-02-28
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack is a medical device manufactured by Quidel Corporation. It received FDA 510(k) clearance on 2018-02-28 under approval number K173691. 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 2 analyzer, Sofia 2 Installation Pack?

Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack is a medical device that received FDA 510(k) clearance on 2018-02-28. It is manufactured by Quidel Corporation. The 510(k) number is K173691.

When was Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack approved by the FDA?

Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack received FDA 510(k) clearance on 2018-02-28, under approval number K173691.

What company makes Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack?

Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack is manufactured by Quidel Corporation.

What is the FDA product code for Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack?

The FDA product code for Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack is LSR.

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Related Devices (Code: 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.

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