Cleared Traditional

PICRIC ACID SATURATED SOLUTION

K842922 · E K Ind., Inc. · Pathology
Sep 1984
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K842922 is an FDA 510(k) clearance for the PICRIC ACID SATURATED SOLUTION, a Fixative, Acid Containing (Class I — General Controls, product code LDW), 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 K842922 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 LDW — Fixative, Acid Containing
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010