Cleared Traditional

ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE

K830479 · Hoffmann-La Roche, Inc. · Toxicology
Mar 1983
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K830479 is an FDA 510(k) clearance for the ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE, a Radioimmunoassay, Barbiturate (Class II — Special Controls, product code DKN), submitted by Hoffmann-La Roche, Inc. (Walker, US). The FDA issued a Cleared decision on March 10, 1983, 23 days after receiving the submission on February 15, 1983. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number K830479 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 1983
Decision Date March 10, 1983
Days to Decision 23 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DKN — Radioimmunoassay, Barbiturate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3150