K-number	K160113
Device name	ST AIA-PACK hsE2 Calibrator Set
Applicant	Tosoh Bioscience, Inc.
Product code	JIT
Device class	Class II
Decision date	Feb 17, 2016
Decision	Substantially Equivalent
Regulation	862.1150

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Source

View the full FDA submission: accessdata.fda.gov

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ST AIA-PACK hsE2 Calibrator Set

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