K-number	K133851
Device name	ALERE PBP2A SA/CONS CULTURE COLONY TEST
Applicant	Alere Scarborough, Inc.
Product code	MYI
Device class	Class II
Decision date	Sep 3, 2014
Decision	Substantially Equivalent
Regulation	866.1640

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View the full FDA submission: accessdata.fda.gov

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ALERE PBP2A SA/CONS CULTURE COLONY TEST

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