Cleared Traditional

K833167 - TRICHROME STAIN LG SOLUTION

K833167 is an FDA 510(k) clearance for TRICHROME STAIN LG SOLUTION, manufactured by Sigma Chemical Co.. The device is a Class 1 Hematology device with product code LED cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K833167 · Sigma Chemical Co. · Hematology device
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Oct 1983
Decision
45d
Days
Class 1
Risk

K833167 is an FDA 510(k) clearance for the TRICHROME STAIN LG SOLUTION. Classified as Stains, Chemical Solution (product code LED), 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 45 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.1850 - the FDA hematology 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

FDA 510(k) Submission Details - K833167

510(k) Number K833167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1983
Decision Date October 31, 1983
Days to Decision 45 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 113d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

LED Device Classification - Class 1, General Controls

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

All 8
Devices cleared under the same product code (LED) and FDA review panel - the closest regulatory comparables to K833167.
GOMORI'S TRICHROME STAIN
K842930 · E K Ind., Inc. · Sep 1984
SUPERMOUNT
K842727 · E K Ind., Inc. · Aug 1984
PRESERV GOMORI TRICHROME STAIN 125/500
K840087 · Preventive Diagnostics Corp. · Feb 1984
IRON STAIN PROCEDURE HT20
K833388 · Sigma Chemical Co. · Oct 1983
LACTO-PHENOL ANILINE BLUE MOUNTING FLUID
K812192 · American Scientific Products · Aug 1981