Cleared Traditional

Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls

K143502 · Immunalysis Corporation · Toxicology

May 2015

Decision

161d

Days

Class 2

Risk

About This 510(k) Submission

K143502 is an FDA 510(k) clearance for the Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on May 20, 2015, 161 days after receiving the submission on December 10, 2014. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number	K143502 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 10, 2014
Decision Date	May 20, 2015
Days to Decision	161 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF