K-number	K190152
Device name	Vit Kit- Freeze NX and Vit Kit- Warm NX
Applicant	Fujifilm Irvine Scientific, Inc.
Product code	MQL
Device class	Class II
Decision date	Jun 21, 2019
Decision	Substantially Equivalent
Regulation	884.6180

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Source

View the full FDA submission: accessdata.fda.gov

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Vit Kit- Freeze NX and Vit Kit- Warm NX

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