Cleared Traditional

CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO

K930208 · Heraeus Kulzer, Inc. · Toxicology

Apr 1993

Decision

95d

Days

Class 1

Risk

About This 510(k) Submission

K930208 is an FDA 510(k) clearance for the CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO, a Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase (Class I — General Controls, product code DLI), submitted by Heraeus Kulzer, Inc. (Tarrytown, US). The FDA issued a Cleared decision on April 20, 1993, 95 days after receiving the submission on January 15, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3240.

Submission Details

510(k) Number	K930208 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 15, 1993
Decision Date	April 20, 1993
Days to Decision	95 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