K-number	DEN170029
Device name	PrimeStore MTM
Applicant	Longhorn Vaccines and Diagnostics, LLC
Product code	QBD
Device class	Class II
Decision date	Mar 19, 2018
Decision	Not Substantially Equivalent
Regulation	866.2950

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Source

View the full FDA submission: accessdata.fda.gov

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PrimeStore MTM

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