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Vit Kit- Freeze NX and Vit Kit- Warm NX

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190152
510(k) Type
Traditional
Applicant
FUJIFILM Irvine Scientific, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/21/2019
Days to Decision
142 days
Submission Type
Summary

Vit Kit- Freeze NX and Vit Kit- Warm NX

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190152
510(k) Type
Traditional
Applicant
FUJIFILM Irvine Scientific, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/21/2019
Days to Decision
142 days
Submission Type
Summary