K-number	K130055
Device name	ACON BUP ONE STEP BUPRENORPHINE TEST STRIP
Applicant	Guangzhou Wondfo Biotech Co., Ltd.
Product code	DJG
Device class	Class II
Decision date	Feb 14, 2013
Decision	Substantially Equivalent
Regulation	862.3650

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Source

View the full FDA submission: accessdata.fda.gov

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ACON BUP ONE STEP BUPRENORPHINE TEST STRIP

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