Cleared Traditional

DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD

K950180 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology

Mar 1995

Decision

57d

Days

Class 1

Risk

About This 510(k) Submission

K950180 is an FDA 510(k) clearance for the DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD, a Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase (Class I — General Controls, product code DLI), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on March 15, 1995, 57 days after receiving the submission on January 17, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3240.

Submission Details

510(k) Number	K950180 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 17, 1995
Decision Date	March 15, 1995
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF

Device Classification

Product Code	DLI — Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.3240