Cleared Traditional

CARNOY'S SOLUTION

K842737 · E K Ind., Inc. · Pathology
Sep 1984
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K842737 is an FDA 510(k) clearance for the CARNOY'S SOLUTION, a Solution, Carnoy's (Class I — General Controls, product code IGM), submitted by E K Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 7, 1984, 56 days after receiving the submission on July 13, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K842737 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1984
Decision Date September 07, 1984
Days to Decision 56 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code IGM — Solution, Carnoy's
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010