Cleared Traditional

K771024 - CHOLINESTERASE REAGENT SYSTEM
(FDA 510(k) Clearance)

K771024 · American Monitor Corp. · Chemistry

Jul 1977

Decision

37d

Days

Class 1

Risk

K771024 is an FDA 510(k) clearance for the CHOLINESTERASE REAGENT SYSTEM, a Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase (Class I — General Controls, product code DLI), submitted by American Monitor Corp. (Mchenry, US). The FDA issued a Cleared decision on July 15, 1977, 37 days after receiving the submission on June 8, 1977. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3240.

Submission Details

510(k) Number	K771024 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 08, 1977
Decision Date	July 15, 1977
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

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