QUIDEL MOLECULAR HMPV ASSAY— 510(k) K112490

Substantially Equivalent

Quidel Corp.

FDA 510(k) clearance K112490 for QUIDEL MOLECULAR HMPV ASSAY, Substantially Equivalent on 2011-12-15. 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: 2011-08-29
Decision date: 2011-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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