Cleared Traditional

K842934 - DECOLORIZING FLUIC, ACID-ALCOHOL 3% (FDA 510(k) Clearance)

Class I Pathology device.

K842934 · E K Ind., Inc. · Pathology device
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Sep 1984
Decision
49d
Days
Class 1
Risk

K842934 is an FDA 510(k) clearance for the DECOLORIZING FLUIC, ACID-ALCOHOL 3%. Classified as General Purpose Reagent (product code PPM), Class I - General Controls.

Submitted by E K Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1984 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.4010 - the FDA pathology device 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 E K Ind., Inc. devices

Submission Details

510(k) Number K842934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1984
Decision Date September 12, 1984
Days to Decision 49 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 77d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PPM General Purpose Reagent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.4010
Definition A General Purpose Reagent Is A Chemical Reagent That Has General Laboratory Application, That Is Used To Collect, Prepare, And Examine Specimens From The Human Body For Diagnostic Purposes, And That Is Not Labeled Or Otherwise Intended For A Specific Diagnostic Application. It May Be Either An Individual Substance, Or Multiple Substances Reformulated, Which, When Combined With Or Used In Conjunction With An Appropriate Analyte Specific Reagent (asr) And Other General Purpose Reagents, Is Part Of A Diagnostic Test Procedure Or System Constituting A Finished In Vitro Diagnostic (ivd) Test.
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.