Cleared Traditional

K863503 - HEMOLYSE (FDA 510(k) Clearance)

Class I Hematology device.

K863503 · Reagent Laboratory, Inc. · Hematology device
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Oct 1986
Decision
24d
Days
Class 1
Risk

K863503 is an FDA 510(k) clearance for the HEMOLYSE. Classified as Products, Red-cell Lysing Products (product code GGK), Class I - General Controls.

Submitted by Reagent Laboratory, Inc. (Louisville, US). The FDA issued a Cleared decision on October 3, 1986 after a review of 24 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.

View all Reagent Laboratory, Inc. devices

Submission Details

510(k) Number K863503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1986
Decision Date October 03, 1986
Days to Decision 24 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 113d · This submission: 24d
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.