Cleared Traditional

K842733 - GRAM IODINE
(FDA 510(k) Clearance)

K842733 · E K Ind., Inc. · Pathology device

Aug 1984

Decision

28d

Days

Class 1

Risk

K842733 is an FDA 510(k) clearance for the GRAM IODINE. This device is classified as a Iodine, Grams (Class I - General Controls, product code HYI).

Submitted by E K Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1984, 28 days after receiving the submission on July 13, 1984.

This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number	K842733 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 13, 1984
Decision Date	August 10, 1984
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—