Cleared Traditional

K860350 - SERUM CHOLINESTERASE REAGENT SET
(FDA 510(k) Clearance)

K860350 · Sterling Diagnostics, Inc. · Chemistry

Apr 1986

Decision

84d

Days

Class 1

Risk

K860350 is an FDA 510(k) clearance for the SERUM CHOLINESTERASE REAGENT SET, a Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase (Class I — General Controls, product code DLI), submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on April 24, 1986, 84 days after receiving the submission on January 30, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3240.

Submission Details

510(k) Number	K860350 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 1986
Decision Date	April 24, 1986
Days to Decision	84 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