Cleared Traditional

K833273 - MASSON TRICHROME STAIN HT15 (FDA 510(k) Clearance)

Class I Pathology device.

K833273 · Sigma Chemical Co. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1983
Decision
40d
Days
Class 1
Risk

K833273 is an FDA 510(k) clearance for the MASSON TRICHROME STAIN HT15. Classified as Biebrich Scarlet (product code ICN), Class I - General Controls.

Submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1983 after a review of 40 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 Chemical Co. devices

Submission Details

510(k) Number K833273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1983
Decision Date October 31, 1983
Days to Decision 40 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 77d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ICN Biebrich Scarlet
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.