Cleared Traditional

K893663 - INSTANT EOSIN-AQUEOUS

K893663 is the FDA 510(k) clearance for INSTANT EOSIN-AQUEOUS by Shandon, Inc.. It is a Class 1 Pathology device (product code HYB) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K893663 · Shandon, Inc. · Pathology device
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Jun 1989
Decision
29d
Days
Class 1
Risk

K893663 is an FDA 510(k) clearance for the INSTANT EOSIN-AQUEOUS. Classified as Eosin Y (product code HYB), Class I - General Controls.

Submitted by Shandon, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on June 13, 1989 after a review of 29 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 Shandon, Inc. devices

Submission Details

510(k) Number K893663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1989
Decision Date June 13, 1989
Days to Decision 29 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 77d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 K893663.
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
VOLU-SOL EOSIN Y STAIN
K800942 · Volu Sol Medical Industries · May 1980