Cleared Traditional

ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE

K830481 · Hoffmann-La Roche, Inc. · Toxicology
Mar 1983
Decision
37d
Days
—
Risk

About This 510(k) Submission

K830481 is an FDA 510(k) clearance for the ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE, a Radioimmunoassay, Phencyclidine, submitted by Hoffmann-La Roche, Inc. (Walker, US). The FDA issued a Cleared decision on March 24, 1983, 37 days after receiving the submission on February 15, 1983. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K830481 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 1983
Decision Date March 24, 1983
Days to Decision 37 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code LCL — Radioimmunoassay, Phencyclidine
Device Class —

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