Cleared Traditional

K871286 - GRAM IODINE
(FDA 510(k) Clearance)

K871286 · Remel Co. · Pathology device

Apr 1987

Decision

Days

Class 1

Risk

K871286 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 Remel Co. (Lenexa, US). The FDA issued a Cleared decision on April 8, 1987, 8 days after receiving the submission on March 31, 1987.

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

Submission Details

510(k) Number	K871286 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 31, 1987
Decision Date	April 08, 1987
Days to Decision	8 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—