Cleared Traditional

ABUSCREEN FP FOR PHENCYCLIDINE

K890882 · Roche Diagnostic Systems, Inc. · Toxicology
Mar 1989
Decision
22d
Days
—
Risk

About This 510(k) Submission

K890882 is an FDA 510(k) clearance for the ABUSCREEN FP FOR PHENCYCLIDINE, a Radioimmunoassay, Phencyclidine, submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on March 15, 1989, 22 days after receiving the submission on February 21, 1989. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K890882 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 1989
Decision Date March 15, 1989
Days to Decision 22 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code LCL — Radioimmunoassay, Phencyclidine
Device Class —

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