Cleared Traditional

SODIUM HYPOCHLORITE 7% (K831619) - FDA 510(k) Clearance

Class I Hematology device.

K831619 · Omega Medical Diagnostics · Hematology device
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Jul 1983
Decision
70d
Days
Class 1
Risk

K831619 is an FDA 510(k) clearance for the SODIUM HYPOCHLORITE 7%. Classified as General Purpose Reagent (product code PPM), Class I - General Controls.

Submitted by Omega Medical Diagnostics (Mchenry, US). The FDA issued a Cleared decision on July 28, 1983 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.4010 - the FDA hematology 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.

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Submission Details

510(k) Number K831619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1983
Decision Date July 28, 1983
Days to Decision 70 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 113d · This submission: 70d
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.