Cleared Traditional

K864074 - ELASTIC STAIN (FDA 510(k) Clearance)

Class I Pathology device.

K864074 · Sigma Diagnostics, Inc. · Pathology device
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Oct 1986
Decision
9d
Days
Class 1
Risk

K864074 is an FDA 510(k) clearance for the ELASTIC STAIN. Classified as Van Gieson's Stain (product code IAC), Class I - General Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 29, 1986 after a review of 9 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K864074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1986
Decision Date October 29, 1986
Days to Decision 9 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 77d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IAC Van Gieson'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.