K-number	K153417
Device name	ST AIA-PACK PROG III Calibrator Set
Applicant	Tosoh Bioscience, Inc.
Product code	JIT
Device class	Class II
Decision date	Dec 18, 2015
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 PROG III Calibrator Set

Everything you need for a 510(k) submission. Nothing you don't.