Cleared Traditional

GOMORI'S TRICHROME STAIN

K842930 · E K Ind., Inc. · Pathology

Sep 1984

Decision

48d

Days

Class 1

Risk

About This 510(k) Submission

K842930 is an FDA 510(k) clearance for the GOMORI'S TRICHROME STAIN, a Stains, Chemical Solution (Class I — General Controls, product code LED), submitted by E K Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 11, 1984, 48 days after receiving the submission on July 25, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number	K842930 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 1984
Decision Date	September 11, 1984
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—