Cleared Traditional

K013096 - PHENCYCLIDINE (FDA 510(k) Clearance)

K013096 · Abbott Laboratories · Toxicology device

Mar 2002

Decision

177d

Days

—

Risk

K013096 is an FDA 510(k) clearance for the PHENCYCLIDINE. This device is classified as a Enzyme Immunoassay, Phencyclidine.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on March 13, 2002, 177 days after receiving the submission on September 17, 2001.

This device falls under the Toxicology FDA review panel.

Submission Details

510(k) Number	K013096 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 17, 2001
Decision Date	March 13, 2002
Days to Decision	177 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF