Cleared Traditional

K874484 - REVISED LABELING FOR TDX PHENCYCLIDINE (FDA 510(k) Clearance)

K874484 · Abbott Laboratories · Toxicology device

Nov 1987

Decision

24d

Days

—

Risk

K874484 is an FDA 510(k) clearance for the REVISED LABELING FOR TDX PHENCYCLIDINE. This device is classified as a Radioimmunoassay, Phencyclidine.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 23, 1987, 24 days after receiving the submission on October 30, 1987.

This device falls under the Toxicology FDA review panel.

Submission Details

510(k) Number	K874484 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 30, 1987
Decision Date	November 23, 1987
Days to Decision	24 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—

Device Classification

Product Code	LCL — Radioimmunoassay, Phencyclidine
Device Class	—