Name: Predicase
Price: 199 USD

K-number	K072115
Device name	ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H
Applicant	Horiba Abx
Product code	CGX
Device class	Class II
Decision date	Nov 30, 2007
Decision	Substantially Equivalent
Regulation	862.1225

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Source

View the full FDA submission: accessdata.fda.gov

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ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H

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