Cleared Traditional

K912888 - URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL
(FDA 510(k) Clearance)

K912888 · Dynagen, Inc. · Toxicology device
Feb 1992
Decision
238d
Days
—
Risk

K912888 is an FDA 510(k) clearance for the URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL. This device is classified as a Strip, Test Isoniazid.

Submitted by Dynagen, Inc. (Cambridge, US). The FDA issued a Cleared decision on February 24, 1992, 238 days after receiving the submission on July 1, 1991.

This device falls under the Toxicology FDA review panel.

Submission Details

510(k) Number K912888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1991
Decision Date February 24, 1992
Days to Decision 238 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code MIG — Strip, Test Isoniazid
Device Class —