Cleared Traditional

K830186 - LYSIS +

K830186 is an FDA 510(k) clearance for LYSIS +, manufactured by Hematology Marketing Assoc.. The device is a Class 1 Pathology device with product code GGK cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K830186 · Hematology Marketing Assoc. · Pathology device
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Feb 1983
Decision
40d
Days
Class 1
Risk

K830186 is an FDA 510(k) clearance for the LYSIS +. Classified as Products, Red-cell Lysing Products (product code GGK), Class I - General Controls.

Submitted by Hematology Marketing Assoc. (Walker, US). The FDA issued a Cleared decision on February 28, 1983 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.8540 - 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 Hematology Marketing Assoc. devices

FDA 510(k) Submission Details - K830186

510(k) Number K830186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1983
Decision Date February 28, 1983
Days to Decision 40 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 77d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

GGK Device Classification - Class 1, General Controls

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 16
Devices cleared under the same product code (GGK) and FDA review panel - the closest regulatory comparables to K830186.
ACETIC ACID, 3% V/V
K842936 · E K Ind., Inc. · Sep 1984
ACETIC ACID 2% V/V
K842937 · E K Ind., Inc. · Sep 1984
LYSING & HEMOGLOBIN REAGENT
K841800 · Reagent Laboratory, Inc. · May 1984
ELUAID
K812002 · Ortho Diagnostic Systems, Inc. · Oct 1981
SERA-PAK TOTAL PROTEIN REAGENT
K802742 · Miles Laboratories, Inc. · Dec 1980
FLUID, RHEMOX W LYSING
K790029 · Sysmex Corp. · Feb 1979