QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199— 510(k) K061008

Name: FDA 510(k) clearance K061008
Creator: U.S. Food and Drug Administration
Published: 2006-09-08

Substantially Equivalent

Quidel Corp.

FDA 510(k) clearance K061008 for QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199, Substantially Equivalent on 2006-09-08. Applicant: Quidel Corp.. Device class: 1.

Clearance details

Applicant: Quidel Corp.
Product code: Code MCE
Device class: Class 1
Regulation: 21 CFR 866.3480
Advisory panel: Microbiology
Date received: 2006-04-12
Decision date: 2006-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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