Quidel Triage® TOX Drug Screen, 94600— 510(k) K200363

Name: FDA 510(k) clearance K200363
Creator: U.S. Food and Drug Administration
Published: 2020-03-11

Substantially Equivalent

Quidel Cardiovascular, Inc.

FDA 510(k) clearance K200363 for Quidel Triage® TOX Drug Screen, 94600, Substantially Equivalent on 2020-03-11. Applicant: Quidel Cardiovascular, Inc.. Device class: 2.

Clearance details

Applicant: Quidel Cardiovascular, Inc.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2020-02-14
Decision date: 2020-03-11
Decision: Substantially Equivalent
Clearance type: Special
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.