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ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160757
510(k) Type
Traditional
Applicant
AXIS-SHIELD DIAGNOSTICS LIMITED
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
7/26/2016
Days to Decision
130 days
Submission Type
Summary

ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160757
510(k) Type
Traditional
Applicant
AXIS-SHIELD DIAGNOSTICS LIMITED
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
7/26/2016
Days to Decision
130 days
Submission Type
Summary