Cleared Traditional

K934358 - KODAK EKTACHEM DT SLIDES (FE)

K934358 is an FDA 510(k) clearance for KODAK EKTACHEM DT SLIDES (FE), manufactured by Eastman Kodak Company. The device is a Class 1 Chemistry device with product code JQE cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K934358 · Eastman Kodak Company · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
194d
Days
Class 1
Risk

K934358 is an FDA 510(k) clearance for the KODAK EKTACHEM DT SLIDES (FE). Classified as Resin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity (product code JQE), Class I - General Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on March 21, 1994 after a review of 194 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1415 - 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 Eastman Kodak Company devices

FDA 510(k) Submission Details - K934358

510(k) Number K934358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1993
Decision Date March 21, 1994
Days to Decision 194 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 88d · This submission: 194d
Pathway characteristics
Predicate-based equivalence.

JQE Device Classification - Class 1, General Controls

Product Code JQE Resin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1415
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 - JQE Resin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity

Devices cleared under the same product code (JQE) and FDA review panel - the closest regulatory comparables to K934358.
CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM
K970248 · Canyon Diagnostics, Inc. · Feb 1997
J&S PEDIATRIC IRON SATURATING REAGENT
K910672 · J.S. Medical Assoc. · Apr 1991
TOTAL IRON BINDING CAPACITY TEST
K884649 · Sclavo, Inc. · Dec 1988
TIBC PRETREATMENT KIT
K842019 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1984