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CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K131727
510(k) Type
Traditional
Applicant
CERAGEM MEDISYS INC.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
2/28/2014
Days to Decision
261 days
Submission Type
Summary

CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K131727
510(k) Type
Traditional
Applicant
CERAGEM MEDISYS INC.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
2/28/2014
Days to Decision
261 days
Submission Type
Summary