QUICKVUE ADVANCE PH AND AMINES GLL TEST— 510(k) K040008

Name: FDA 510(k) clearance K040008
Creator: U.S. Food and Drug Administration
Published: 2004-04-29

Substantially Equivalent

Quidel Corp.

FDA 510(k) clearance K040008 for QUICKVUE ADVANCE PH AND AMINES GLL TEST, Substantially Equivalent on 2004-04-29. Applicant: Quidel Corp.. Device class: 1.

Clearance details

Applicant: Quidel Corp.
Product code: Code CEN
Device class: Class 1
Regulation: 21 CFR 862.1550
Advisory panel: Clinical Chemistry
Date received: 2004-01-02
Decision date: 2004-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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