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Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K140496
510(k) Type
Special
Applicant
BECKMAN COULTER, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/16/2014
Days to Decision
201 days
Submission Type
Summary

Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K140496
510(k) Type
Special
Applicant
BECKMAN COULTER, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/16/2014
Days to Decision
201 days
Submission Type
Summary