Cleared Traditional

DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK

K934147 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology
Nov 1993
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K934147 is an FDA 510(k) clearance for the DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK, a Enzyme Immunoassay, Methadone (Class II — Special Controls, product code DJR), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on November 9, 1993, 76 days after receiving the submission on August 25, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3620.

Submission Details

510(k) Number K934147 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 1993
Decision Date November 09, 1993
Days to Decision 76 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJR — Enzyme Immunoassay, Methadone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3620

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