Name: Predicase
Price: 199 USD

K-number	K093957
Device name	ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,
Applicant	Fujirebio Diagnostics,Inc.
Product code	OIU
Device class	Class II
Decision date	Mar 18, 2010
Decision	Substantially Equivalent
Regulation	866.6010

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View the full FDA submission: accessdata.fda.gov

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ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,

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