Cleared Traditional

CHOLINESTERASE

K863111 · J. D. Assoc. · Toxicology
Sep 1986
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K863111 is an FDA 510(k) clearance for the CHOLINESTERASE, a Colorimetry, Cholinesterase (Class I — General Controls, product code DIH), submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on September 11, 1986, 29 days after receiving the submission on August 13, 1986. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3240.

Submission Details

510(k) Number K863111 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 1986
Decision Date September 11, 1986
Days to Decision 29 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DIH — Colorimetry, Cholinesterase
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3240

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