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Dimension Hemoglobin A1c Assay

Page Type
Cleared 510(K)
510(k) Number
K173909
510(k) Type
Traditional
Applicant
Siemens Healthcare Diagnostics Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/13/2018
Days to Decision
203 days
Submission Type
Summary

Dimension Hemoglobin A1c Assay

Page Type
Cleared 510(K)
510(k) Number
K173909
510(k) Type
Traditional
Applicant
Siemens Healthcare Diagnostics Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/13/2018
Days to Decision
203 days
Submission Type
Summary