Cleared Traditional

ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100

K961620 · Roche Diagnostic Systems, Inc. · Toxicology
Jun 1996
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K961620 is an FDA 510(k) clearance for the ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100, a Radioimmunoassay, Cannabinoid(s) (Class II — Special Controls, product code LAT), submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on June 13, 1996, 48 days after receiving the submission on April 26, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K961620 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 1996
Decision Date June 13, 1996
Days to Decision 48 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

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

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