Cleared Traditional

ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD

K860525 · Roche Diagnostic Systems, Inc. · Toxicology
Apr 1986
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K860525 is an FDA 510(k) clearance for the ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD, 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 April 11, 1986, 59 days after receiving the submission on February 11, 1986. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3580.

Submission Details

510(k) Number K860525 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 1986
Decision Date April 11, 1986
Days to Decision 59 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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