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VITROS XT Chemistry Products UREA-CREA Slides

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190326
510(k) Type
Traditional
Applicant
Ortho-Clinical Diagnostics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/14/2019
Days to Decision
29 days
Submission Type
Summary

VITROS XT Chemistry Products UREA-CREA Slides

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190326
510(k) Type
Traditional
Applicant
Ortho-Clinical Diagnostics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/14/2019
Days to Decision
29 days
Submission Type
Summary