Name: Predicase
Price: 199 USD

K-number	K080960
Device name	PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS
Applicant	Abbott Diabetes Care, Inc.
Product code	NBW
Device class	Class II
Decision date	Sep 5, 2008
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS

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