Name: Predicase
Price: 199 USD

K-number	K080696
Device name	ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01
Applicant	Abbott Laboratories
Product code	DIP
Device class	Class II
Decision date	Sep 11, 2008
Decision	Substantially Equivalent
Regulation	862.3350

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Source

View the full FDA submission: accessdata.fda.gov

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ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01

Everything you need for a 510(k) submission. Nothing you don't.