Cleared Traditional

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI) (K924488) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924488 · Eastman Kodak Company · Chemistry device
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Jan 1993
Decision
145d
Days
Class 2
Risk

K924488 is an FDA 510(k) clearance for the KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI). Classified as Flame Photometry, Lithium (product code JIH), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on January 26, 1993 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3560 - 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 K924488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1992
Decision Date January 26, 1993
Days to Decision 145 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
57d slower than avg
Panel avg: 88d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIH Flame Photometry, Lithium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JIH Flame Photometry, Lithium

Devices cleared under the same product code (JIH) and FDA review panel - the closest regulatory comparables to K924488.
DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132
K011033 · Dade Behring, Inc. · Jun 2001
KODAK EKTACHEM DTSC II SLIDES (LI)
K934106 · Eastman Kodak Company · Apr 1994
AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE
K895465 · Baxter Healthcare Corp · Dec 1989
TDX(R) LITES(TM) LITHIUM
K894328 · Abbott Laboratories · Nov 1989