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ELECSYS TESTOSTERONE II IMMUNOASSAY

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K093421
510(k) Type
Traditional
Applicant
ROCHE DIAGNOSTICS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/23/2010
Days to Decision
171 days
Submission Type
Summary

ELECSYS TESTOSTERONE II IMMUNOASSAY

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K093421
510(k) Type
Traditional
Applicant
ROCHE DIAGNOSTICS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/23/2010
Days to Decision
171 days
Submission Type
Summary