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ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K112443
510(k) Type
Traditional
Applicant
AXIS-SHIELD DIAGNOSTICS, LTD.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
12/19/2011
Days to Decision
117 days
Submission Type
Summary

ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K112443
510(k) Type
Traditional
Applicant
AXIS-SHIELD DIAGNOSTICS, LTD.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
12/19/2011
Days to Decision
117 days
Submission Type
Summary