Cleared Traditional

K842744 - WRIGHT STAIN

K842744 is an FDA 510(k) clearance for WRIGHT STAIN, manufactured by E K Ind., Inc.. The device is a Class 1 Pathology device with product code IAF cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K842744 · E K Ind., Inc. · Pathology device
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Aug 1984
Decision
30d
Days
Class 1
Risk

K842744 is an FDA 510(k) clearance for the WRIGHT STAIN. Classified as Wright's Stain (product code IAF), Class I - General Controls.

Submitted by E K Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1984 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1850 - 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 E K Ind., Inc. devices

FDA 510(k) Submission Details - K842744

510(k) Number K842744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1984
Decision Date August 12, 1984
Days to Decision 30 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 77d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

IAF Device Classification - Class 1, General Controls

Product Code IAF Wright's Stain
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.1850
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 - IAF Wright's Stain

All 18
Devices cleared under the same product code (IAF) and FDA review panel - the closest regulatory comparables to K842744.
WRIGHT-GLEMSA STAIN
K890673 · Sigma Diagnostics, Inc. · Feb 1989
ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET
K890674 · Sigma Diagnostics, Inc. · Feb 1989
HEMATOLOGY STAIN PACK
K853241 · Fisher Scientific Co., LLC · Aug 1985
WRIGHT-GIEMSA QUICK STAIN
K842745 · E K Ind., Inc. · Aug 1984
HEMATOLOGY WRIGHT'S STAIN PACK
K833678 · J.S. Medical Assoc. · Nov 1983
HEMAQUIK II STAINING SOLUTION #55961
K830542 · Accra Laboratories, Inc. · Mar 1983