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CAPILLARYS Hb A1c

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171861
510(k) Type
Traditional
Applicant
Sebia
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/7/2018
Days to Decision
230 days
Submission Type
Summary

CAPILLARYS Hb A1c

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171861
510(k) Type
Traditional
Applicant
Sebia
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/7/2018
Days to Decision
230 days
Submission Type
Summary