Last synced on 23 September 2022 at 11:05 pm

Elecsys Testosterone II

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211685
510(k) Type
Traditional
Applicant
Roche Diagnostics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/6/2022
Days to Decision
338 days
Submission Type
Summary

Elecsys Testosterone II

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211685
510(k) Type
Traditional
Applicant
Roche Diagnostics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/6/2022
Days to Decision
338 days
Submission Type
Summary