Cleared Traditional

AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup

K151211 · Assure Tech. Co., Ltd. · Toxicology

Jun 2015

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K151211 is an FDA 510(k) clearance for the AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup, a Enzyme Immunoassay, Barbiturate (Class II — Special Controls, product code DIS), submitted by Assure Tech. Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on June 4, 2015, 29 days after receiving the submission on May 6, 2015. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number	K151211 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 06, 2015
Decision Date	June 04, 2015
Days to Decision	29 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF