K-number	K170481
Device name	Strep B Carrot Broth Kit
Applicant	Hardy Diagnostics
Product code	PQZ
Device class	Class I
Decision date	May 16, 2017
Decision	Substantially Equivalent
Regulation	866.2360

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Source

View the full FDA submission: accessdata.fda.gov

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Strep B Carrot Broth Kit

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