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ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172133
510(k) Type
Special
Applicant
Axis-Shield Diagnostics Ltd.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
10/27/2017
Days to Decision
105 days
Submission Type
Summary

ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172133
510(k) Type
Special
Applicant
Axis-Shield Diagnostics Ltd.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
10/27/2017
Days to Decision
105 days
Submission Type
Summary