Cleared Traditional

K823480 - IL 943 FLAME PHOTOMETER

K823480 is the FDA 510(k) clearance for IL 943 FLAME PHOTOMETER by Instrumentation Laboratory CO. It is a Class 1 Chemistry device (product code JJO) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K823480 · Instrumentation Laboratory CO · Chemistry device
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Jan 1983
Decision
47d
Days
Class 1
Risk

K823480 is an FDA 510(k) clearance for the IL 943 FLAME PHOTOMETER. Classified as Flame Emission Photometer For Clinical Use (product code JJO), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Walker, US). The FDA issued a Cleared decision on January 9, 1983 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2540 - 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.

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Submission Details

510(k) Number K823480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1982
Decision Date January 09, 1983
Days to Decision 47 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
41d faster than avg
Panel avg: 88d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJO Flame Emission Photometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2540
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 - JJO Flame Emission Photometer For Clinical Use

Devices cleared under the same product code (JJO) and FDA review panel - the closest regulatory comparables to K823480.
OLYMPUS AU 5000 FLAME PHOTOMETER MODULE
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CORNING 480 FLAME PHOTOMETER
K820631 · Corning Medical & Scientific · Apr 1982
FLAME PHOTOMETER, MODEL 435
K780649 · Corning Medical & Scientific · May 1978
FLAME PHOTOMETER, MODEL 455
K780650 · Corning Medical & Scientific · May 1978
I.L. MODEL 643 FLAME PHOTOMETER
K771337 · Instrumentation Laboratory CO · Oct 1977