K-number	K161364
Device name	BinaxNOW G6PD Test
Applicant	Alere Scarborough, Inc.
Product code	JBF
Device class	Class II
Decision date	Jun 17, 2016
Decision	Substantially Equivalent
Regulation	864.7360

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Source

View the full FDA submission: accessdata.fda.gov

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BinaxNOW G6PD Test

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