Cleared Traditional

K884176 - CHROMATOGRAPHY KIT
(FDA 510(k) Clearance)

K884176 · Gelman Sciences, Inc. · Toxicology device

Apr 1989

Decision

182d

Days

Class 1

Risk

K884176 is an FDA 510(k) clearance for the CHROMATOGRAPHY KIT. This device is classified as a Apparatus, General Use, Thin Layer Chromatography (Class I - General Controls, product code DPA).

Submitted by Gelman Sciences, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on April 4, 1989, 182 days after receiving the submission on October 4, 1988.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2270.

Submission Details

510(k) Number	K884176 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 04, 1988
Decision Date	April 04, 1989
Days to Decision	182 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—