Cleared Traditional

SERUM CHOLINESTERASE REAGENT SET

K833062 · Sterling Biochemical, Inc. · Chemistry

Nov 1983

Decision

78d

Days

Class 1

Risk

About This 510(k) Submission

K833062 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 Biochemical, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 25, 1983, 78 days after receiving the submission on September 8, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3240.

Submission Details

510(k) Number	K833062 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 08, 1983
Decision Date	November 25, 1983
Days to Decision	78 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