Cleared Special

UCP MULTIPLE DRUG SCREEN TEST CUPS

K072062 · Ucp Biosciences, Inc. · Toxicology
Sep 2007
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K072062 is an FDA 510(k) clearance for the UCP MULTIPLE DRUG SCREEN TEST CUPS, a Radioimmunoassay, Tricyclic Antidepressant Drugs (Class II — Special Controls, product code LFG), submitted by Ucp Biosciences, Inc. (San Jose, US). The FDA issued a Cleared decision on September 20, 2007, 55 days after receiving the submission on July 27, 2007. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3910.

Submission Details

510(k) Number K072062 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 2007
Decision Date September 20, 2007
Days to Decision 55 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LFG — Radioimmunoassay, Tricyclic Antidepressant Drugs
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3910
Definition Intended To Measure Any Of The Tricyclic Antidepressant Drugs In Serum Or Urine.

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