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HbA1c Advanced

Page Type
Cleared 510(K)
510(k) Number
K182651
510(k) Type
Traditional
Applicant
Beckman Coulter Ireland Inc.
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
1/16/2019
Days to Decision
114 days
Submission Type
Summary

HbA1c Advanced

Page Type
Cleared 510(K)
510(k) Number
K182651
510(k) Type
Traditional
Applicant
Beckman Coulter Ireland Inc.
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
1/16/2019
Days to Decision
114 days
Submission Type
Summary