K-number	K152526
Device name	Elecsys Progesterone III CalSet
Applicant	Roche Diagnostics
Product code	JIT
Device class	Class II
Decision date	Oct 2, 2015
Decision	Substantially Equivalent
Regulation	862.1150

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Source

View the full FDA submission: accessdata.fda.gov

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Elecsys Progesterone III CalSet

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