Cleared Traditional

K812002 - ELUAID

K812002 is an FDA 510(k) clearance for ELUAID, manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 1 Hematology device with product code GGK cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K812002 · Ortho Diagnostic Systems, Inc. · Hematology device
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Oct 1981
Decision
106d
Days
Class 1
Risk

K812002 is an FDA 510(k) clearance for the ELUAID. Classified as Products, Red-cell Lysing Products (product code GGK), Class I - General Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on October 28, 1981 after a review of 106 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 Ortho Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K812002

510(k) Number K812002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1981
Decision Date October 28, 1981
Days to Decision 106 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 113d · This submission: 106d
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 15
Devices cleared under the same product code (GGK) and FDA review panel - the closest regulatory comparables to K812002.
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
SERA-PAK TOTAL PROTEIN REAGENT
K802742 · Miles Laboratories, Inc. · Dec 1980
FLUID, RHEMOX W LYSING
K790029 · Sysmex Corp. · Feb 1979
REAGENT, LYSING AND HEMOGLOBIN
K782098 · Dade, Baxter Travenol Diagnostics, Inc. · Jan 1979