Name: Predicase
Price: 199 USD

K-number	K062180
Device name	ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP
Applicant	Horiba Abx
Product code	JFJ
Device class	Class II
Decision date	Oct 2, 2006
Decision	Substantially Equivalent
Regulation	862.1070

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Source

View the full FDA submission: accessdata.fda.gov

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ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP

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