Cleared Traditional

RED CELL LYSING REAGENT 78N 1915-1 (K822324) - FDA 510(k) Clearance

Class I Hematology device.

K822324 · Interscience, Inc. · Hematology device
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Nov 1982
Decision
97d
Days
Class 1
Risk

K822324 is an FDA 510(k) clearance for the RED CELL LYSING REAGENT 78N 1915-1. Classified as Products, Red-cell Lysing Products (product code GGK), Class I - General Controls.

Submitted by Interscience, Inc. (Walker, US). The FDA issued a Cleared decision on November 8, 1982 after a review of 97 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Interscience, Inc. devices

Submission Details

510(k) Number K822324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1982
Decision Date November 08, 1982
Days to Decision 97 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 113d · This submission: 97d
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.