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FDA 510(k) Applications Submitted by CO-INNOVATION BIOTECH CO., LTD.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K140215
01/28/2014
ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD
CO-INNOVATION BIOTECH CO., LTD.
K131110
04/19/2013
ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD
CO-INNOVATION BIOTECH CO., LTD.
K132085
07/05/2013
ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM
CO-INNOVATION BIOTECH CO., LTD.
K142800
09/29/2014
Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard
Co-Innovation Biotech Co., Ltd.
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