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FDA 510(k)

SOFIA STREP A FIA

K-Number: K123793 · 2013-06-17

ApplicantQuidel Corporation
Decision Date2013-06-17
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SOFIA STREP A 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 2013-06-17 under 510(k) number K123793. 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 STREP A FIA is a medical device that received FDA 510(k) clearance on 2013-06-17. The listed applicant is Quidel Corporation. The 510(k) number is K123793.

When did SOFIA STREP A FIA receive FDA 510(k) clearance?

SOFIA STREP A FIA received FDA 510(k) clearance on 2013-06-17, under 510(k) number K123793.

Who is the listed applicant for SOFIA STREP A 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 STREP A FIA?

The FDA product code for SOFIA STREP A FIA is GTY.

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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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