Cleared Traditional

URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE

K950427 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology
Mar 1995
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K950427 is an FDA 510(k) clearance for the URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE, a Enzyme Immunoassay, Benzodiazepine (Class II — Special Controls, product code JXM), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on March 21, 1995, 47 days after receiving the submission on February 2, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3170.

Submission Details

510(k) Number K950427 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 1995
Decision Date March 21, 1995
Days to Decision 47 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code JXM — Enzyme Immunoassay, Benzodiazepine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3170

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