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FDA 510(k)

QUIDEL MOLECULAR RSV + HMPV ASSAY

K-Number: K122189 · 2013-03-08

ApplicantQuidel Corp.
Decision Date2013-03-08
Product CodeOEM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUIDEL MOLECULAR RSV + HMPV 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 2013-03-08 under 510(k) number K122189. The device is classified under product code OEM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIDEL MOLECULAR RSV + HMPV ASSAY?

QUIDEL MOLECULAR RSV + HMPV ASSAY is a medical device that received FDA 510(k) clearance on 2013-03-08. The listed applicant is Quidel Corp.. The 510(k) number is K122189.

When did QUIDEL MOLECULAR RSV + HMPV ASSAY receive FDA 510(k) clearance?

QUIDEL MOLECULAR RSV + HMPV ASSAY received FDA 510(k) clearance on 2013-03-08, under 510(k) number K122189.

Who is the listed applicant for QUIDEL MOLECULAR RSV + HMPV 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 RSV + HMPV ASSAY?

The FDA product code for QUIDEL MOLECULAR RSV + HMPV ASSAY is OEM.

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Other records listing Quidel Corp. as applicant

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.

K131813QUIDEL MOLECULAR RSV + HMPV ASSAYK131728QUIDEL MOLECULAR INFLUENZA A + B ASSAYK130398SOFIA(R) RSV FIAK131166SOFIA(R) HCG FIAK131606SOFIA INFLUENZA A+B FIAK131619QUICKVUE INFLUENZA A+B

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Related Devices (Code: OEM)

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.

K230349Lyra RSV+hMPV AssayQuidel CorporationK132200PRO HMPV+ ASSAYGen-Probe Prodesse, Inc.K123838PRO HMPV+ ASSAYGen-Probe Prodesse, Inc.K112490QUIDEL MOLECULAR HMPV ASSAYQuidel Corp.K082688PRO HMPV+ ASSAYProdesse, 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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