K-number	DEN180056
Device name	GSP Neonatal Creatine Kinase - MM kit
Applicant	Perkinelmer, Inc.
Product code	QJE
Device class	Class II
Decision date	Dec 12, 2019
Decision	Not Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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GSP Neonatal Creatine Kinase - MM kit

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