Cleared Traditional

K854176 - POLYCHROME IV STAIN

K854176 is the FDA 510(k) clearance for POLYCHROME IV STAIN by Devetec, Inc.. It is a Class 1 Pathology device (product code LED) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K854176 · Devetec, Inc. · Pathology device
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Oct 1985
Decision
16d
Days
Class 1
Risk

K854176 is an FDA 510(k) clearance for the POLYCHROME IV STAIN. Classified as Stains, Chemical Solution (product code LED), Class I - General Controls.

Submitted by Devetec, Inc. (Bradenton, US). The FDA issued a Cleared decision on October 31, 1985 after a review of 16 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 Devetec, Inc. devices

Submission Details

510(k) Number K854176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1985
Decision Date October 31, 1985
Days to Decision 16 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 77d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LED Stains, Chemical Solution
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 - LED Stains, Chemical Solution

Devices cleared under the same product code (LED) and FDA review panel - the closest regulatory comparables to K854176.
SPOTTEST CALCOFLUOR WHITE REAGENT
K860795 · Difco Laboratories, Inc. · Mar 1986
SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR
K851481 · Difco Laboratories, Inc. · Apr 1985
GOMORI'S TRICHROME STAIN
K842930 · E K Ind., Inc. · Sep 1984
SUPERMOUNT
K842727 · E K Ind., Inc. · Aug 1984
TRICHROME STAIN LG SOLUTION
K833167 · Sigma Chemical Co. · Oct 1983
IRON STAIN PROCEDURE HT20
K833388 · Sigma Chemical Co. · Oct 1983