K-number	K885003
Device name	BACTIGEN(R) GROUP B STREPTOCOCCUS TEST
Applicant	Armkel, LLC
Product code	GTZ
Device class	Class I
Decision date	Feb 7, 1989
Decision	Substantially Equivalent
Regulation	866.3740

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View the full FDA submission: accessdata.fda.gov

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BACTIGEN(R) GROUP B STREPTOCOCCUS TEST

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