Cleared Traditional

K880011 - REVISED LABELING FOR ADX PHENCYCLIDINE (FDA 510(k) Clearance)

K880011 · Abbott Laboratories · Toxicology device

Feb 1988

Decision

38d

Days

—

Risk

K880011 is an FDA 510(k) clearance for the REVISED LABELING FOR ADX PHENCYCLIDINE. This device is classified as a Radioimmunoassay, Phencyclidine.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 11, 1988, 38 days after receiving the submission on January 4, 1988.

This device falls under the Toxicology FDA review panel.

Submission Details

510(k) Number	K880011 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 04, 1988
Decision Date	February 11, 1988
Days to Decision	38 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—

Device Classification

Product Code	LCL — Radioimmunoassay, Phencyclidine
Device Class	—