Cleared Traditional

K884771 - IL PHOENIX

K884771 is the FDA 510(k) clearance for IL PHOENIX by Instrumentation Laboratory CO. It is a Class 2 Chemistry device (product code JFP) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K884771 · Instrumentation Laboratory CO · Chemistry device
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Feb 1989
Decision
88d
Days
Class 2
Risk

K884771 is an FDA 510(k) clearance for the IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY. Classified as Electrode, Ion Specific, Calcium (product code JFP), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on February 10, 1989 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - 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 K884771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1988
Decision Date February 10, 1989
Days to Decision 88 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
At panel average
Panel avg: 88d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFP Electrode, Ion Specific, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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 - JFP Electrode, Ion Specific, Calcium

All 9
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