Last synced on 14 November 2025 at 11:06 pm

CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM

Page Type
Cleared 510(K)
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)
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