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Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K140654
510(k) Type
Traditional
Applicant
ABBOTT LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/22/2015
Days to Decision
434 days
Submission Type
Summary

Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K140654
510(k) Type
Traditional
Applicant
ABBOTT LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/22/2015
Days to Decision
434 days
Submission Type
Summary