Cleared Traditional

K843426 - EOSIN Y 1% ALCOHOLIC

K843426 is an FDA 510(k) clearance for EOSIN Y 1% ALCOHOLIC, manufactured by Accra Laboratories, Inc.. The device is a Class 1 Pathology device with product code HYB cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K843426 · Accra Laboratories, Inc. · Pathology device
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Sep 1984
Decision
23d
Days
Class 1
Risk

K843426 is an FDA 510(k) clearance for the EOSIN Y 1% ALCOHOLIC. Classified as Eosin Y (product code HYB), Class I - General Controls.

Submitted by Accra Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1984 after a review of 23 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 Accra Laboratories, Inc. devices

FDA 510(k) Submission Details - K843426

510(k) Number K843426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1984
Decision Date September 27, 1984
Days to Decision 23 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
54d faster than avg
Panel avg: 77d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

HYB Device Classification - Class 1, General Controls

Product Code HYB Eosin Y
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 - HYB Eosin Y

Devices cleared under the same product code (HYB) and FDA review panel - the closest regulatory comparables to K843426.
EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE
K880596 · Sigma Chemical Co. · Mar 1988
MIDAS 100 HEMACOLOR STAIN #66030
K822982 · Emd Chemicals, Inc. · Oct 1982
EOSIN Y SOLUTIN, AGUEOUS
K821574 · Sigma Chemical Co. · Jun 1982
EOSIN Y SOLUTION ALCHOLIC
K821573 · Sigma Chemical Co. · Jun 1982
EOSIN-Y
K811797 · Richard-Allan Medical Ind., Inc. · Jul 1981
VOLU-SOL EOSIN Y STAIN
K800942 · Volu Sol Medical Industries · May 1980