Name: Predicase
Price: 199 USD

K-number	K082953
Device name	ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01
Applicant	Biokit, S.A.
Product code	KXT
Device class	Class II
Decision date	Dec 22, 2008
Decision	Substantially Equivalent
Regulation	862.3320

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Source

View the full FDA submission: accessdata.fda.gov

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ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01

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