Cleared Traditional

STAIN, METHYLENE BLUE-EOSIN

K842785 · Reagent Laboratory, Inc. · Pathology
Sep 1984
Decision
71d
Days
Class 1
Risk

About This 510(k) Submission

K842785 is an FDA 510(k) clearance for the STAIN, METHYLENE BLUE-EOSIN, a Methylene Blue, Tissue Stain (Class I — General Controls, product code KFC), submitted by Reagent Laboratory, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 11, 1984, 71 days after receiving the submission on July 2, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K842785 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 1984
Decision Date September 11, 1984
Days to Decision 71 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KFC — Methylene Blue, Tissue Stain
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850