Name: Predicase
Price: 199 USD

K-number	K123171
Device name	ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT
Applicant	HORIBA ABX SAS
Product code	CJY
Device class	Class II
Decision date	Jul 3, 2013
Decision	Substantially Equivalent
Regulation	862.1145

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Source

View the full FDA submission: accessdata.fda.gov

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ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT

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