Cleared Traditional

K924471 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE...

K924471 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 JGS) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K924471 · Eastman Kodak Company · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
65d
Days
Class 2
Risk

K924471 is an FDA 510(k) clearance for the KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL). Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on November 6, 1992 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1665 - 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 K924471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1992
Decision Date November 06, 1992
Days to Decision 65 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
23d faster than avg
Panel avg: 88d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JGS Electrode, Ion Specific, Sodium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1665
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 - JGS Electrode, Ion Specific, Sodium

All 115
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K924471.
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NOVA 8 CRT ANALYZER
K924547 · Nova Biomedical Corp. · Jan 1993
ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATER
K923806 · Nova Biomedical Corp. · Sep 1992
NOVA NUCLEUS CLINICAL CHEMICAL SYST, MODIFICATION
K921937 · Nova Biomedical Corp. · Jul 1992
OLYMPUS ISE MODULE
K921718 · Olympus Corp. · Jul 1992