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Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151529
510(k) Type
Traditional
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/11/2016
Days to Decision
248 days
Submission Type
Summary

Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151529
510(k) Type
Traditional
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/11/2016
Days to Decision
248 days
Submission Type
Summary