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Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151786
510(k) Type
Traditional
Applicant
Roche Diagnostics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/24/2015
Days to Decision
85 days
Submission Type
Summary

Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151786
510(k) Type
Traditional
Applicant
Roche Diagnostics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/24/2015
Days to Decision
85 days
Submission Type
Summary