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Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno.

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K142362
510(k) Type
Traditional
Applicant
BECKMAN COULTER, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/19/2014
Days to Decision
116 days
Submission Type
Summary

Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno.

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K142362
510(k) Type
Traditional
Applicant
BECKMAN COULTER, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/19/2014
Days to Decision
116 days
Submission Type
Summary