URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE— 510(k) K950427

Name: FDA 510(k) clearance K950427
Creator: U.S. Food and Drug Administration
Published: 1995-03-21

Substantially Equivalent

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

FDA 510(k) clearance K950427 for URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE, Substantially Equivalent on 1995-03-21. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 2.

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code JXM
Device class: Class 2
Regulation: 21 CFR 862.3170
Advisory panel: Clinical Toxicology
Date received: 1995-02-02
Decision date: 1995-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

Download summary PDF View on FDA.gov ↗

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