K-number	K951542
Device name	DIRECTIGEN 1-2-3 GROUP A STREP TEST
Applicant	Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code	GTZ
Device class	Class I
Decision date	Oct 20, 1995
Decision	Substantially Equivalent
Regulation	866.3740

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View the full FDA submission: accessdata.fda.gov

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DIRECTIGEN 1-2-3 GROUP A STREP TEST

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