Cleared Traditional

WRIGHT STAIN FIXATIVE

K842913 · E K Ind., Inc. · Pathology
Sep 1984
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K842913 is an FDA 510(k) clearance for the WRIGHT STAIN FIXATIVE, a Fixative, Alcohol Containing (Class I — General Controls, product code LDZ), submitted by E K Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 7, 1984, 44 days after receiving the submission on July 25, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K842913 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 1984
Decision Date September 07, 1984
Days to Decision 44 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code LDZ — Fixative, Alcohol Containing
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010

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