K-number	K011663
Device name	MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS
Applicant	The Binding Site, Ltd.
Product code	DEM
Device class	Class II
Decision date	Jul 30, 2001
Decision	Substantially Equivalent
Regulation	866.5130

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MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS

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