Cleared Traditional

REVISED LABELING FOR ADX PHENCYCLIDINE

K880011 · Abbott Laboratories · Toxicology
Feb 1988
Decision
38d
Days
—
Risk

About This 510(k) Submission

K880011 is an FDA 510(k) clearance for the REVISED LABELING FOR ADX PHENCYCLIDINE, 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 review panel.

Submission Details

510(k) Number K880011 FDA.gov
FDA Decision Cleared 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 —

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