Cleared Traditional

K020313 - ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE
(FDA 510(k) Clearance)

K020313 · Acon Laboratories Co. · Toxicology

May 2002

Decision

98d

Days

Class 2

Risk

K020313 is an FDA 510(k) clearance for the ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE. This device is classified as a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ).

Submitted by Acon Laboratories Co. (San Diego, US). The FDA issued a Cleared decision on May 8, 2002, 98 days after receiving the submission on January 30, 2002.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number	K020313 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 2002
Decision Date	May 08, 2002
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF