K-number	K050625
Device name	VARELISA RECOMBI ANA PROFILE, MODEL 18496
Applicant	Sweden Diagnostics (Germany) GmbH
Product code	LJM
Device class	Class II
Decision date	Apr 26, 2005
Decision	Substantially Equivalent
Regulation	866.5100

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View the full FDA submission: accessdata.fda.gov

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VARELISA RECOMBI ANA PROFILE, MODEL 18496

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