Cleared Traditional

K832182 - LYSING REAGENT

K832182 is the FDA 510(k) clearance for LYSING REAGENT by Omega Medical Diagnostics. It is a Class 1 Hematology device (product code GGK) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K832182 · Omega Medical Diagnostics · Hematology device
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Aug 1983
Decision
36d
Days
Class 1
Risk

K832182 is an FDA 510(k) clearance for the LYSING REAGENT. Classified as Products, Red-cell Lysing Products (product code GGK), Class I - General Controls.

Submitted by Omega Medical Diagnostics (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8540 - 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 K832182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1983
Decision Date August 12, 1983
Days to Decision 36 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 113d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GGK Products, Red-cell Lysing Products
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.8540
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 - GGK Products, Red-cell Lysing Products

All 10
Devices cleared under the same product code (GGK) and FDA review panel - the closest regulatory comparables to K832182.
ACETIC ACID, 5% V/V
K842935 · E K Ind., Inc. · Sep 1984
ACETIC ACID, 3% V/V
K842936 · E K Ind., Inc. · Sep 1984
ACETIC ACID 2% V/V
K842937 · E K Ind., Inc. · Sep 1984
ELUAID
K812002 · Ortho Diagnostic Systems, Inc. · Oct 1981
SERA-PAK TOTAL PROTEIN REAGENT
K802742 · Miles Laboratories, Inc. · Dec 1980
REAGENT, LYSING AND HEMOGLOBIN
K782098 · Dade, Baxter Travenol Diagnostics, Inc. · Jan 1979