Cleared Traditional

ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD

K131110 · Co-Innovation Biotech Co., Ltd. · Toxicology
Jan 2014
Decision
271d
Days
Class 2
Risk

About This 510(k) Submission

K131110 is an FDA 510(k) clearance for the ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Co-Innovation Biotech Co., Ltd. (Guangzhou, Guangdong, CN). The FDA issued a Cleared decision on January 15, 2014, 271 days after receiving the submission on April 19, 2013. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K131110 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2013
Decision Date January 15, 2014
Days to Decision 271 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DKZ — Enzyme Immunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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