Name: Predicase
Price: 199 USD

K-number	K200898
Device name	Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin
Applicant	Medicon Hellas S.A
Product code	CIX
Device class	Class II
Decision date	Sep 21, 2021
Decision	Substantially Equivalent
Regulation	862.1035

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Source

View the full FDA submission: accessdata.fda.gov

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Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin

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