Cleared Traditional

REVISED LABELING FOR LSD TEST KIT

K874270 · Roche Diagnostic Systems, Inc. · Toxicology
Nov 1987
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K874270 is an FDA 510(k) clearance for the REVISED LABELING FOR LSD TEST KIT, a Radioimmunoassay, Lsd (125-i) (Class II — Special Controls, product code DLB), submitted by Roche Diagnostic Systems, Inc. (Nutley, US). The FDA issued a Cleared decision on November 13, 1987, 24 days after receiving the submission on October 20, 1987. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3580.

Submission Details

510(k) Number K874270 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 1987
Decision Date November 13, 1987
Days to Decision 24 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

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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