Cleared Traditional

K844586 - IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS

K844586 is an FDA 510(k) clearance for IL GENESIS 21, manufactured by Instrumentation Laboratory CO. The device is a Class 1 Chemistry device with product code JJF cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K844586 · Instrumentation Laboratory CO · Chemistry device
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Dec 1984
Decision
18d
Days
Class 1
Risk

K844586 is an FDA 510(k) clearance for the IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS. Classified as Analyzer, Chemistry, Micro, For Clinical Use (product code JJF), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on December 11, 1984 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2170 - 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

FDA 510(k) Submission Details - K844586

510(k) Number K844586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1984
Decision Date December 11, 1984
Days to Decision 18 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
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

JJF Device Classification - Class 1, General Controls

Product Code JJF Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2170
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 - JJF Analyzer, Chemistry, Micro, For Clinical Use

All 44
Devices cleared under the same product code (JJF) and FDA review panel - the closest regulatory comparables to K844586.
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SHABAN 9865 IL#78637 JUNCTION BLOC
K833804 · Shaban Mfg. Co. · Jan 1984
NOVA 9 SODIUM/POTASSIUM/TOTAL CALCIUM
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