QUICKVUE ONE-STEP ALLERGEN SCREEN— 510(k) K950728

Substantially Equivalent

Quidel Corp.

FDA 510(k) clearance K950728 for QUICKVUE ONE-STEP ALLERGEN SCREEN, Substantially Equivalent on 1995-10-02. Applicant: Quidel Corp.. Device class: 2.

Clearance details

Applicant: Quidel Corp.
Product code: Code DHB
Device class: Class 2
Regulation: 21 CFR 866.5750
Advisory panel: Immunology
Date received: 1995-02-16
Decision date: 1995-10-02
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.