K-number	K020823
Device name	PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT
Applicant	Sanquin Blood Supply Foundation
Product code	DFZ
Device class	Class II
Decision date	May 14, 2002
Decision	Substantially Equivalent
Regulation	866.5510

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View the full FDA submission: accessdata.fda.gov

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PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT

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