Cleared Traditional

K934358 - KODAK EKTACHEM DT SLIDES (FE) (FDA 510(k) Clearance)

Class I Chemistry device.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 88d · This submission: 194d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.