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ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K131244
510(k) Type
Traditional
Applicant
Roche Diagnostics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/27/2014
Days to Decision
271 days
Submission Type
Summary

ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K131244
510(k) Type
Traditional
Applicant
Roche Diagnostics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/27/2014
Days to Decision
271 days
Submission Type
Summary