ACCU NEWS Drug Screening Test Card/Urine Cup— 510(k) K152590

Name: FDA 510(k) clearance K152590
Creator: U.S. Food and Drug Administration
Published: 2016-04-15

Substantially Equivalent

Coretests, Inc.

FDA 510(k) clearance K152590 for ACCU NEWS Drug Screening Test Card/Urine Cup, Substantially Equivalent on 2016-04-15. Applicant: Coretests, Inc.. Device class: 2.

Clearance details

Applicant: Coretests, Inc.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2015-09-10
Decision date: 2016-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, 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.