Cleared Traditional

ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT)

K961436 · Roche Diagnostic Systems, Inc. · Toxicology
Jun 1996
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K961436 is an FDA 510(k) clearance for the ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT), a Radioimmunoassay, Lsd (125-i) (Class II — Special Controls, product code DLB), submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on June 21, 1996, 67 days after receiving the submission on April 15, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3580.

Submission Details

510(k) Number K961436 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1996
Decision Date June 21, 1996
Days to Decision 67 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DLB — Radioimmunoassay, Lsd (125-i)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3580

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