K-number	K895022
Device name	SYSTEMATE CREATININE TEST (CREA) #65413
Applicant	Em Diagnostic Systems, Inc.
Product code	CGX
Device class	Class II
Decision date	Oct 23, 1989
Decision	Substantially Equivalent
Regulation	862.1225

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View the full FDA submission: accessdata.fda.gov

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SYSTEMATE CREATININE TEST (CREA) #65413

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