Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro— 510(k) K182719

Name: FDA 510(k) clearance K182719
Creator: U.S. Food and Drug Administration
Published: 2019-06-19

Substantially Equivalent

Quidel Cardiovascular, Inc.

FDA 510(k) clearance K182719 for Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro, Substantially Equivalent on 2019-06-19. 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: 2018-09-28
Decision date: 2019-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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