QUIDEL MOLECULAR RSV + HMPV ASSAY— 510(k) K122189

Substantially Equivalent

Quidel Corp.

FDA 510(k) clearance K122189 for QUIDEL MOLECULAR RSV + HMPV ASSAY, Substantially Equivalent on 2013-03-08. Applicant: Quidel Corp.. Device class: 2.

Clearance details

Applicant: Quidel Corp.
Product code: Code OEM
Device class: Class 2
Regulation: 21 CFR 866.3980
Advisory panel: Microbiology
Date received: 2012-07-24
Decision date: 2013-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Quidel Corp.

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K131166 — SOFIA(R) HCG FIA2013-08-02
K131606 — SOFIA INFLUENZA A+B FIA2013-07-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.