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IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161831
510(k) Type
Traditional
Applicant
Immunodiagnostic Systems Ltd
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
11/15/2016
Days to Decision
133 days
Submission Type
Summary

IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161831
510(k) Type
Traditional
Applicant
Immunodiagnostic Systems Ltd
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
11/15/2016
Days to Decision
133 days
Submission Type
Summary