Cleared Traditional

KODAK EKTACHEM FOUR CHEMISTRY ANALYZER (K800053) - FDA 510(k) Clearance

Class I Chemistry device.

K800053 · Eastman Kodak Company · Chemistry device
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Jan 1980
Decision
14d
Days
Class 1
Risk

K800053 is an FDA 510(k) clearance for the KODAK EKTACHEM FOUR CHEMISTRY ANALYZER. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Eastman Kodak Company (Mchenry, US). The FDA issued a Cleared decision on January 23, 1980 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2160 - 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 K800053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1980
Decision Date January 23, 1980
Days to Decision 14 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
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
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 - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

All 76
Devices cleared under the same product code (JJE) and FDA review panel - the closest regulatory comparables to K800053.
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AUTOMATED IMMUOCHEMISTRY SYSTEM
K803267 · Beckman Instruments, Inc. · Jan 1981
ANALYZER ABA-200
K782014 · Abbott Laboratories · Jan 1979
ANALYZER, 100, BICHROMATIC, ABBOTT
K780388 · Syva Co. · Mar 1978
MODEL 2/2 ANALYZER
K771245 · Eastman Kodak Company · Oct 1977