Cleared Traditional

K903144 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE...

K903144 is the FDA 510(k) clearance for KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE... by Eastman Kodak Company. It is a Class 2 Chemistry device (product code KHS) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K903144 · Eastman Kodak Company · Chemistry device
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Sep 1990
Decision
69d
Days
Class 2
Risk

K903144 is an FDA 510(k) clearance for the KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (ECO2). Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on September 25, 1990 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1160 - 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

Submission Details

510(k) Number K903144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1990
Decision Date September 25, 1990
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 88d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHS Enzymatic, Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1160
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 - KHS Enzymatic, Carbon-dioxide

All 65
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K903144.
ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22
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TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD
K903305 · Technicon Instruments Corp. · Sep 1990
BICARBONATE REAGENTS AMRESCO PRODUCT #4326020
K904007 · Amresco, Inc. · Sep 1990
COULTER CARBON DIOXIDE REAGENT
K902229 · Coulter Corp. · Jun 1990
CARBON DIOXIDE REAGENT
K896812 · Pointe Scientific, Inc., · Feb 1990