ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD— 510(k) K131110

Clearance details

Applicant

Co-Innovation Biotech Co., Ltd.

Product code

Code DKZ

Device class

Class 2

Regulation

21 CFR 862.3100

Advisory panel

Clinical Toxicology

Date received

2013-04-19

Decision date

2014-01-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Guangzhou, Guangdong, CN

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