K-number	K123256
Device name	HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
Applicant	The Binding Site Group , Ltd.
Product code	DEM
Device class	Class II
Decision date	Jul 3, 2013
Decision	Substantially Equivalent
Regulation	866.5130

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Source

View the full FDA submission: accessdata.fda.gov

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HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS

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