Cleared Traditional

MILENIA COCAINE METABOLITE

K910044 · Diagnostic Products Corp. · Toxicology
Feb 1991
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K910044 is an FDA 510(k) clearance for the MILENIA COCAINE METABOLITE, a Radioimmunoassay, Cocaine Metabolite (Class II — Special Controls, product code KLN), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on February 13, 1991, 40 days after receiving the submission on January 4, 1991. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K910044 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 1991
Decision Date February 13, 1991
Days to Decision 40 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code KLN — Radioimmunoassay, Cocaine Metabolite
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250

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