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Tina-quant Transferrin ver.2 (urine application)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182095
510(k) Type
Traditional
Applicant
Roche Diagnostics Operations (RDO)
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/5/2018
Days to Decision
94 days
Submission Type
Summary

Tina-quant Transferrin ver.2 (urine application)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182095
510(k) Type
Traditional
Applicant
Roche Diagnostics Operations (RDO)
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/5/2018
Days to Decision
94 days
Submission Type
Summary