Cleared Traditional

ABUSCREEN RADIOIMMUNOASSAY-COCAINE META

K830480 · Hoffmann-La Roche, Inc. · Toxicology
Mar 1983
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K830480 is an FDA 510(k) clearance for the ABUSCREEN RADIOIMMUNOASSAY-COCAINE META, a Radioimmunoassay, Cocaine Metabolite (Class II — Special Controls, product code KLN), 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. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K830480 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 KLN — Radioimmunoassay, Cocaine Metabolite
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250

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