Cleared Traditional

NEW METHYLENE BLUE N

K842743 · E K Ind., Inc. · Hematology
Aug 1984
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K842743 is an FDA 510(k) clearance for the NEW METHYLENE BLUE N, 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 August 12, 1984, 30 days after receiving the submission on July 13, 1984. This device falls under the Hematology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K842743 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1984
Decision Date August 12, 1984
Days to Decision 30 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

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