Cleared Traditional

K913198 - KODAK EKTACHEM DT SLIDES (CHE)

K913198 is an FDA 510(k) clearance for KODAK EKTACHEM DT SLIDES (CHE), manufactured by Eastman Kodak Company. The device is a Class 1 Chemistry device with product code DIH cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K913198 · Eastman Kodak Company · Chemistry device
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Aug 1991
Decision
39d
Days
Class 1
Risk

K913198 is an FDA 510(k) clearance for the KODAK EKTACHEM DT SLIDES (CHE). Classified as Colorimetry, Cholinesterase (product code DIH), Class I - General Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on August 26, 1991 after a review of 39 days - a notably fast clearance cycle.

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: 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 Eastman Kodak Company devices

FDA 510(k) Submission Details - K913198

510(k) Number K913198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1991
Decision Date August 26, 1991
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 88d · This submission: 39d
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 K913198.
TEST-MATE CHE CHOLINESTERASE TEST SYSTEM
K961656 · Eqm Research, Inc. · Nov 1996
IL TEST CHOLINESTERASE
K943367 · Instrumentation Laboratory CO · Feb 1996
CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05
K955498 · Diagnostic Chemicals , Ltd. · Jan 1996
CHOLINESTERASE TEST KIT
K912148 · Crestat Diagnostics, Inc. · Aug 1991
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K912217 · Eastman Kodak Company · Jul 1991
CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE
K885272 · Sigma Chemical Co. · Mar 1989