Cleared Traditional

K863111 - CHOLINESTERASE

K863111 is the FDA 510(k) clearance for CHOLINESTERASE by J. D. Assoc.. It is a Class 1 Toxicology device (product code DIH) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

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

K863111 is an FDA 510(k) clearance for the CHOLINESTERASE. Classified as Colorimetry, Cholinesterase (product code DIH), Class I - General Controls.

Submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on September 11, 1986 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3240 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all J. D. Assoc. devices

Submission Details

510(k) Number K863111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1986
Decision Date September 11, 1986
Days to Decision 29 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 87d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIH Colorimetry, Cholinesterase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3240
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DIH Colorimetry, Cholinesterase

All 17
Devices cleared under the same product code (DIH) and FDA review panel - the closest regulatory comparables to K863111.
DU PONT DIMENSION PSEUDOCHOLINESTERASE METHOD
K883890 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1988
CHOLINESTERASE (BTC) REAGENT
K863203 · Sigma Diagnostics, Inc. · Sep 1986
CHOLINESTERASE (PTC) REAGENT
K863202 · Sigma Diagnostics, Inc. · Sep 1986
RAICHEM CHOLINESTERASE REAGENT
K862168 · Reagents Applications, Inc. · Jun 1986
CHOLINESTERASE REAGENT
K791725 · Gilford Diagnostics · Oct 1979