FDA 510(k)

QUIDEL MOLECULAR INFLUENZA A + B ASSAY

K-Number: K131728 · 2013-08-29

Decision Date2013-08-29

Product CodeOZE

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

QUIDEL MOLECULAR INFLUENZA A + B ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 2013-08-29 under 510(k) number K131728. The device is classified under product code OZE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIDEL MOLECULAR INFLUENZA A + B ASSAY?

QUIDEL MOLECULAR INFLUENZA A + B ASSAY is a medical device that received FDA 510(k) clearance on 2013-08-29. The listed applicant is Quidel Corp.. The 510(k) number is K131728.

When did QUIDEL MOLECULAR INFLUENZA A + B ASSAY receive FDA 510(k) clearance?

QUIDEL MOLECULAR INFLUENZA A + B ASSAY received FDA 510(k) clearance on 2013-08-29, under 510(k) number K131728.

Who is the listed applicant for QUIDEL MOLECULAR INFLUENZA A + B ASSAY?

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

What is the FDA product code for QUIDEL MOLECULAR INFLUENZA A + B ASSAY?

The FDA product code for QUIDEL MOLECULAR INFLUENZA A + B ASSAY is OZE.

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Other records listing Quidel Corp. as applicant

K131813QUIDEL MOLECULAR RSV + HMPV ASSAY K130398SOFIA(R) RSV FIA K131166SOFIA(R) HCG FIA K131606SOFIA INFLUENZA A+B FIA K131619QUICKVUE INFLUENZA A+B K122189QUIDEL MOLECULAR RSV + HMPV ASSAY

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Related Devices (Code: OZE)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.