Cleared Traditional

K842740 - DELAFIELD HEMATOXYLIN STAIN

K842740 is an FDA 510(k) clearance for DELAFIELD HEMATOXYLIN STAIN, manufactured by E K Ind., Inc.. The device is a Class 1 Pathology device with product code HYJ cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K842740 · E K Ind., Inc. · Pathology device
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Aug 1984
Decision
35d
Days
Class 1
Risk

K842740 is an FDA 510(k) clearance for the DELAFIELD HEMATOXYLIN STAIN. Classified as Hematoxylin (product code HYJ), Class I - General Controls.

Submitted by E K Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 17, 1984 after a review of 35 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.

FDA 510(k) Submission Details - K842740

510(k) Number K842740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1984
Decision Date August 17, 1984
Days to Decision 35 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
43d faster than avg
Panel avg: 78d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

HYJ Device Classification - Class 1, General Controls

Product Code HYJ Hematoxylin
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 - HYJ Hematoxylin

All 13
Devices cleared under the same product code (HYJ) and FDA review panel - the closest regulatory comparables to K842740.
ANATECH HEMATOXYLIN-NORMAL STRENGTH
K872499 · Anatech, Ltd. · Jul 1987
ANATECH HEMATOXYLIN-EXTRA STRENGTH
K872500 · Anatech, Ltd. · Jul 1987
GILL HEMATOXYLIN STAIN
K842741 · E K Ind., Inc. · Aug 1984
HEMATOXYLIN GILL FORMULATION IX#56016
K831090 · Accra Laboratories, Inc. · Jun 1983
HEMATOXYLIN STAIN SOLUTION
K822352 · Fisher Scientific Co., LLC · Aug 1982
HEMATOXYLIN I
K821533 · Volu Sol Medical Industries · Jun 1982
K842740 · DELAFIELD HEMATOXYLIN STAIN
Download PDF E K Ind., Inc.