Cleared Traditional

MASSON TRICHROME STAIN HT15

K833273 · Sigma Chemical Co. · Pathology
Oct 1983
Decision
40d
Days
Class 1
Risk

About This 510(k) Submission

K833273 is an FDA 510(k) clearance for the MASSON TRICHROME STAIN HT15, a Biebrich Scarlet (Class I — General Controls, product code ICN), submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1983, 40 days after receiving the submission on September 21, 1983. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K833273 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 1983
Decision Date October 31, 1983
Days to Decision 40 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code ICN — Biebrich Scarlet
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850