Cleared Traditional

Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard

K142800 · Co-Innovation Biotech Co., Ltd. · Toxicology
Dec 2014
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K142800 is an FDA 510(k) clearance for the Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Co-Innovation Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on December 11, 2014, 73 days after receiving the submission on September 29, 2014. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K142800 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2014
Decision Date December 11, 2014
Days to Decision 73 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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