Name: Predicase
Price: 199 USD

K-number	K974396
Device name	IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE
Applicant	Diametrics Medical, Inc.
Product code	CHL
Device class	Class II
Decision date	Dec 18, 1997
Decision	Substantially Equivalent
Regulation	862.1120

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Source

View the full FDA submission: accessdata.fda.gov

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IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE

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