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VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201312
510(k) Type
Traditional
Applicant
Ortho Clinical Diagnostics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/4/2021
Days to Decision
504 days
Submission Type
Summary

VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201312
510(k) Type
Traditional
Applicant
Ortho Clinical Diagnostics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/4/2021
Days to Decision
504 days
Submission Type
Summary