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FDA 510(k)

Sofia Strep A+ FIA, Sofia 2 Analyzer

K-Number: K171976 · 2017-12-21

ApplicantQuidel Corporation
Decision Date2017-12-21
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Sofia Strep A+ FIA, Sofia 2 Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2017-12-21 under 510(k) number K171976. The device is classified under product code GTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sofia Strep A+ FIA, Sofia 2 Analyzer?

Sofia Strep A+ FIA, Sofia 2 Analyzer is a medical device that received FDA 510(k) clearance on 2017-12-21. The listed applicant is Quidel Corporation. The 510(k) number is K171976.

When did Sofia Strep A+ FIA, Sofia 2 Analyzer receive FDA 510(k) clearance?

Sofia Strep A+ FIA, Sofia 2 Analyzer received FDA 510(k) clearance on 2017-12-21, under 510(k) number K171976.

Who is the listed applicant for Sofia Strep A+ FIA, Sofia 2 Analyzer?

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 Strep A+ FIA, Sofia 2 Analyzer?

The FDA product code for Sofia Strep A+ FIA, Sofia 2 Analyzer is GTY.

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Related Devices (Code: GTY)

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.

K260342AllTest Strep A Rapid TestHangzhou AllTest Biotech Co., Ltd.K251697Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripACON Laboratories, Inc.K212623Healgen Strep A Rapid Test Strip (Throat Swab)Healgen Scientific,, LLC

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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