Cleared Traditional

IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE (K914171) - FDA 510(k) Clearance

Class I Chemistry device.

K914171 · Tech Intl. Co. · Chemistry device
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Dec 1991
Decision
92d
Days
Class 1
Risk

K914171 is an FDA 510(k) clearance for the IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE. Classified as Colorimetry, Cholinesterase (product code DIH), Class I - General Controls.

Submitted by Tech Intl. Co. (Rochester Hills, US). The FDA issued a Cleared decision on December 18, 1991 after a review of 92 days - within the typical 510(k) review window.

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

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Tech Intl. Co. devices

Submission Details

510(k) Number K914171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1991
Decision Date December 18, 1991
Days to Decision 92 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 88d · This submission: 92d
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 K914171.
SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722
K103373 · Beckman Coulter, Inc. · Feb 2011
CHOLINESTERASE GEN.2 TEST SYSTEM
K061093 · Roche Diagnostics Corp. · Jul 2006
IL TEST CHOLINESTERASE
K943367 · Instrumentation Laboratory CO · Feb 1996
KODAK EKTACHEM DT SLIDES (CHE)
K913198 · Eastman Kodak Company · Aug 1991
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K912217 · Eastman Kodak Company · Jul 1991
CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE
K885272 · Sigma Chemical Co. · Mar 1989