Last synced on 14 November 2025 at 11:06 pm

Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5

Page Type
Cleared 510(K)
510(k) Number
K162840
510(k) Type
Traditional
Applicant
Roche Diagnostics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/8/2017
Days to Decision
120 days
Submission Type
Summary

Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5

Page Type
Cleared 510(K)
510(k) Number
K162840
510(k) Type
Traditional
Applicant
Roche Diagnostics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/8/2017
Days to Decision
120 days
Submission Type
Summary