Cleared Traditional

CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05 (K955498) - FDA 510(k) Clearance

Class I Toxicology device.

K955498 · Diagnostic Chemicals , Ltd. · Toxicology device
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Jan 1996
Decision
54d
Days
Class 1
Risk

K955498 is an FDA 510(k) clearance for the CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05. Classified as Colorimetry, Cholinesterase (product code DIH), Class I - General Controls.

Submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E.I., CA). The FDA issued a Cleared decision on January 24, 1996 after a review of 54 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 Diagnostic Chemicals , Ltd. devices

Submission Details

510(k) Number K955498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1995
Decision Date January 24, 1996
Days to Decision 54 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 87d · This submission: 54d
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 25
Devices cleared under the same product code (DIH) and FDA review panel - the closest regulatory comparables to K955498.
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K885272 · Sigma Chemical Co. · Mar 1989