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Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls

Page Type
Cleared 510(K)
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)
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