Cleared Traditional

ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE

K830460 · Hoffmann-La Roche, Inc. · Toxicology

Mar 1983

Decision

37d

Days

Class 2

Risk

About This 510(k) Submission

K830460 is an FDA 510(k) clearance for the ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE, a Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. (Class II — Special Controls, product code DOE), submitted by Hoffmann-La Roche, Inc. (Mchenry, 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 862.3640.

Submission Details

510(k) Number	K830460 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	DOE — Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep.
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.3640