Cleared Traditional

K801026 - IL MODEL 773 FLUORESCENCE LIGHT SCATTER

K801026 is the FDA 510(k) clearance for IL MODEL 773 FLUORESCENCE LIGHT SCATTER by Instrumentation Laboratory CO. It is a Class 1 Chemistry device (product code JJG) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K801026 · Instrumentation Laboratory CO · Chemistry device
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May 1980
Decision
27d
Days
Class 1
Risk

K801026 is an FDA 510(k) clearance for the IL MODEL 773 FLUORESCENCE LIGHT SCATTER. Classified as Analyzer, Chemistry, Centrifugal, For Clinical Use (product code JJG), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on May 28, 1980 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2140 - 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K801026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1980
Decision Date May 28, 1980
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJG Analyzer, Chemistry, Centrifugal, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2140
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 - JJG Analyzer, Chemistry, Centrifugal, For Clinical Use

All 15
Devices cleared under the same product code (JJG) and FDA review panel - the closest regulatory comparables to K801026.
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CENTRIA SYSTEM
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ANALYZER, CENTRIFUCHEM SYSTEM 400
K790278 · Union Carbide Corp. · Apr 1979