Name: Predicase
Price: 199 USD

K-number	K172232
Device name	LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600
Applicant	Ams Diagnostics
Product code	JGS
Device class	Class II
Decision date	Jun 12, 2019
Decision	Substantially Equivalent
Regulation	862.1665

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Source

View the full FDA submission: accessdata.fda.gov

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LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600

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