Cleared Traditional

K932728 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC) (FDA 510(k) Clearance)

Class I Chemistry device.

K932728 · Eastman Kodak Company · Chemistry device
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Optimized for regulatory review, auditing and printing
Apr 1994
Decision
322d
Days
Class 1
Risk

K932728 is an FDA 510(k) clearance for the KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC). Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on April 25, 1994 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1775 - 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. Elevated predicate reliance profile. 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 K932728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1993
Decision Date April 25, 1994
Days to Decision 322 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
234d slower than avg
Panel avg: 88d · This submission: 322d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KNK Acid, Uric, Uricase (colorimetric)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1775
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.