Cleared Traditional

K840606 - EKTACHEM CLINICAL CHEM. SLIDES

K840606 is the FDA 510(k) clearance for EKTACHEM CLINICAL CHEM. SLIDES by Eastman Kodak Company. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K840606 · Eastman Kodak Company · Chemistry device
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Apr 1984
Decision
54d
Days
Class 2
Risk

K840606 is an FDA 510(k) clearance for the EKTACHEM CLINICAL CHEM. SLIDES. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Eastman Kodak Company (Walker, US). The FDA issued a Cleared decision on April 4, 1984 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1110 - 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 K840606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1984
Decision Date April 04, 1984
Days to Decision 54 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
34d faster than avg
Panel avg: 88d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIG Diazo Colorimetry, Bilirubin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1110
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 - CIG Diazo Colorimetry, Bilirubin

All 172
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K840606.
EKTACHEM CLINICAL CHEM. SLIDES
K840880 · Eastman Kodak Company · Apr 1984
NEONATAL BILIRUBIN REAGENT
K840779 · American Dade · Apr 1984
DIRECT BILIRUBIN REAGENT
K840777 · American Dade · Apr 1984
TOTAL BILIRUBIN
K840111 · Fisher Scientific Co., LLC · Mar 1984
LIQUI ZYME TOTAL BILIRUBIN REAGENT
K840564 · American Research Products Co. · Mar 1984
PARAMAX TOTAL BILIRUBIN REAGENT
K833004 · American Dade · Oct 1983