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ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171771
510(k) Type
Traditional
Applicant
Siemens Healthcare Diagnostics Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/4/2017
Days to Decision
173 days
Submission Type
Summary

ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171771
510(k) Type
Traditional
Applicant
Siemens Healthcare Diagnostics Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/4/2017
Days to Decision
173 days
Submission Type
Summary