Sofia 2 Campylobacter FIA
K-Number: K211342 · 2021-11-23
ApplicantQuidel Corporation
Decision Date2021-11-23
Product CodeLQP
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Sofia 2 Campylobacter FIA is a medical device manufactured by Quidel Corporation. It received FDA 510(k) clearance on 2021-11-23 under approval number K211342. The device is classified under product code LQP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sofia 2 Campylobacter FIA?
Sofia 2 Campylobacter FIA is a medical device that received FDA 510(k) clearance on 2021-11-23. It is manufactured by Quidel Corporation. The 510(k) number is K211342.
When was Sofia 2 Campylobacter FIA approved by the FDA?
Sofia 2 Campylobacter FIA received FDA 510(k) clearance on 2021-11-23, under approval number K211342.
What company makes Sofia 2 Campylobacter FIA?
Sofia 2 Campylobacter FIA is manufactured by Quidel Corporation.
What is the FDA product code for Sofia 2 Campylobacter FIA?
The FDA product code for Sofia 2 Campylobacter FIA is LQP.
Other Devices by Quidel Corporation
Related Devices (Code: LQP)
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.