Name: Predicase
Price: 199 USD

K-number	K060768
Device name	PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
Applicant	Abbott Diabetes Care, Inc.
Product code	JIN
Device class	Class I
Decision date	Apr 21, 2006
Decision	Substantially Equivalent
Regulation	862.1435

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Source

View the full FDA submission: accessdata.fda.gov

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PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS

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