Cleared Traditional

K913743 - IL TEST(TM) PHENCYCLIDINE (FDA 510(k) Clearance)

K913743 · Instrumentation Laboratory CO · Toxicology device
Nov 1991
Decision
79d
Days
—
Risk

K913743 is an FDA 510(k) clearance for the IL TEST(TM) PHENCYCLIDINE. This device is classified as a Enzyme Immunoassay, Phencyclidine.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on November 7, 1991, 79 days after receiving the submission on August 20, 1991.

This device falls under the Toxicology FDA review panel.

Submission Details

510(k) Number K913743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1991
Decision Date November 07, 1991
Days to Decision 79 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LCM — Enzyme Immunoassay, Phencyclidine
Device Class —