Cleared Traditional

K904326 - DE-TOX TUBES A AND DE-TOX TUBES B (FDA 510(k) Clearance)

K904326 · Dyna-Tek Industries · Toxicology device

Jan 1991

Decision

119d

Days

Class 1

Risk

K904326 is an FDA 510(k) clearance for the DE-TOX TUBES A AND DE-TOX TUBES B. This device is classified as a Apparatus, General Use, Thin Layer Chromatography (Class I - General Controls, product code DPA).

Submitted by Dyna-Tek Industries (Lenexa, US). The FDA issued a Cleared decision on January 17, 1991, 119 days after receiving the submission on September 20, 1990.

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

Submission Details

510(k) Number	K904326 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 20, 1990
Decision Date	January 17, 1991
Days to Decision	119 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—