K-number	K182472
Device name	Cepheid Xpert GBS LB Control Panel
Applicant	Microbiologics, Inc.
Product code	PMN
Device class	Class II
Decision date	Nov 8, 2018
Decision	Substantially Equivalent
Regulation	866.3920

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View the full FDA submission: accessdata.fda.gov

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Cepheid Xpert GBS LB Control Panel

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