Cleared Traditional

FORMALIN-ACETO-ALCOHOL FIXATIVE

K842731 · E K Ind., Inc. · Pathology

Sep 1984

Decision

60d

Days

Class 1

Risk

About This 510(k) Submission

K842731 is an FDA 510(k) clearance for the FORMALIN-ACETO-ALCOHOL FIXATIVE, a Solution, Formalin-alcohol-acetic Acid (Class I — General Controls, product code IGF), submitted by E K Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 11, 1984, 60 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	K842731 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 1984
Decision Date	September 11, 1984
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—