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Rapid-i™ Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181461
510(k) Type
Traditional
Applicant
Vitrolife Sweden AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
1/4/2019
Days to Decision
214 days
Submission Type
Summary

Rapid-i™ Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181461
510(k) Type
Traditional
Applicant
Vitrolife Sweden AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
1/4/2019
Days to Decision
214 days
Submission Type
Summary