ACA DU PONT URINE OPIATES (U OPI) SCREEN METHOD— 510(k) K872391

Name: FDA 510(k) clearance K872391
Creator: U.S. Food and Drug Administration
Published: 1987-08-10

Substantially Equivalent

E.I. Dupont DE Nemours & Co., Inc.

FDA 510(k) clearance K872391 for ACA DU PONT URINE OPIATES (U OPI) SCREEN METHOD, Substantially Equivalent on 1987-08-10. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 2.

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 1987-06-19
Decision date: 1987-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

Download summary PDF View on FDA.gov ↗

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