Cleared Traditional

UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS

K061457 · Ucp Biosciences, Inc. · Toxicology

Aug 2006

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K061457 is an FDA 510(k) clearance for the UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS, 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 August 21, 2006, 88 days after receiving the submission on May 25, 2006. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3910.

Submission Details

510(k) Number	K061457 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 25, 2006
Decision Date	August 21, 2006
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF

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.