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ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K140436
510(k) Type
Traditional
Applicant
FUJIREBIO DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/23/2014
Days to Decision
305 days
Submission Type
Summary

ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K140436
510(k) Type
Traditional
Applicant
FUJIREBIO DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/23/2014
Days to Decision
305 days
Submission Type
Summary