Cleared Traditional

ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI

K820391 · Hoffmann-La Roche, Inc. · Toxicology
Mar 1982
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K820391 is an FDA 510(k) clearance for the ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI, a Radioimmunoassay, Cannabinoid(s) (Class II — Special Controls, product code LAT), submitted by Hoffmann-La Roche, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 8, 1982, 26 days after receiving the submission on February 10, 1982. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K820391 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 1982
Decision Date March 08, 1982
Days to Decision 26 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code LAT — Radioimmunoassay, Cannabinoid(s)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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