Cleared Traditional

K021526 - ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE
(FDA 510(k) Clearance)

K021526 · ACON Laboratories, Inc. · Chemistry

Jul 2002

Decision

68d

Days

Class 2

Risk

K021526 is an FDA 510(k) clearance for the ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE. This device is classified as a Radioimmunoassay, Tricyclic Antidepressant Drugs (Class II — Special Controls, product code LFG).

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on July 17, 2002, 68 days after receiving the submission on May 10, 2002.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3910. Intended To Measure Any Of The Tricyclic Antidepressant Drugs In Serum Or Urine..

Submission Details

510(k) Number	K021526 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 10, 2002
Decision Date	July 17, 2002
Days to Decision	68 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
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.