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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2021-11-23 under 510(k) 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. The listed applicant is Quidel Corporation. The 510(k) number is K211342.

When did Sofia 2 Campylobacter FIA receive FDA 510(k) clearance?

Sofia 2 Campylobacter FIA received FDA 510(k) clearance on 2021-11-23, under 510(k) number K211342.

Who is the listed applicant for Sofia 2 Campylobacter FIA?

The FDA 510(k) record lists Quidel Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sofia 2 Campylobacter FIA?

The FDA product code for Sofia 2 Campylobacter FIA is LQP.

Other records listing Quidel Corporation as applicant

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Related Devices (Code: LQP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210976Curian CampyMeridian Bioscience, Inc.K191456Campylobacter Quik ChekTechlab, Inc.K191442Campylobacter ChekTechlab, Inc.K173219CAMPYLOBACTER CHEKTechlab, Inc.K173217CAMPYLOBACTER QUIK CHEKTechlab, Inc.

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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