Cleared Traditional

METHYLENE BLUE STAIN, LOEFFLER

K842926 · E K Ind., Inc. · Pathology
Sep 1984
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K842926 is an FDA 510(k) clearance for the METHYLENE BLUE STAIN, LOEFFLER, a Methylene Blue, Tissue Stain (Class I — General Controls, product code KFC), submitted by E K Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 11, 1984, 48 days after receiving the submission on July 25, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K842926 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 1984
Decision Date September 11, 1984
Days to Decision 48 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