Cleared Traditional

ORANGE G, 1%

K842924 · E K Ind., Inc. · Pathology

Sep 1984

Decision

44d

Days

Class 1

Risk

About This 510(k) Submission

K842924 is an FDA 510(k) clearance for the ORANGE G, 1%, a Orange G (Class I — General Controls, product code HZH), 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 864.1850.

Submission Details

510(k) Number	K842924 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	—