Cleared Traditional

K961656 - TEST-MATE CHE CHOLINESTERASE TEST SYSTEM

K961656 is an FDA 510(k) clearance for TEST-MATE CHE CHOLINESTERASE TEST SYSTEM, manufactured by Eqm Research, Inc.. The device is a Class 1 Toxicology device with product code DIH cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K961656 · Eqm Research, Inc. · Toxicology device
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Nov 1996
Decision
210d
Days
Class 1
Risk

K961656 is an FDA 510(k) clearance for the TEST-MATE CHE CHOLINESTERASE TEST SYSTEM. Classified as Colorimetry, Cholinesterase (product code DIH), Class I - General Controls.

Submitted by Eqm Research, Inc. (Cincinnati, US). The FDA issued a Cleared decision on November 26, 1996 after a review of 210 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Eqm Research, Inc. devices

FDA 510(k) Submission Details - K961656

510(k) Number K961656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1996
Decision Date November 26, 1996
Days to Decision 210 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 87d · This submission: 210d
Pathway characteristics
Predicate-based equivalence.

DIH Device Classification - Class 1, General Controls

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 23
Devices cleared under the same product code (DIH) and FDA review panel - the closest regulatory comparables to K961656.
ADVIA 1650 CHOLINESTERASE ASSAY
K013750 · Bayer Diagnostics Corp. · Jan 2002
CARESIDE CHOLINESTERASE
K002792 · Careside, Inc. · Nov 2000
ADVIA IMS
K001344 · Bayer Corp. · Jun 2000
IL TEST CHOLINESTERASE
K943367 · Instrumentation Laboratory CO · Feb 1996
CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05
K955498 · Diagnostic Chemicals , Ltd. · Jan 1996
KODAK EKTACHEM DT SLIDES (CHE)
K913198 · Eastman Kodak Company · Aug 1991