ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD— 510(k) K140215

Clearance details

Applicant

Co-Innovation Biotech Co., Ltd.

Product code

Code DIS

Device class

Class 2

Regulation

21 CFR 862.3150

Advisory panel

Clinical Toxicology

Date received

2014-01-28

Decision date

2014-06-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Guangzhou, Guangdong, CN

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