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ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS

Page Type
Cleared 510(K)
510(k) Number
K013152
510(k) Type
Traditional
Applicant
ELAN HOLDINGS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/9/2001
Days to Decision
50 days
Submission Type
Summary

ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS

Page Type
Cleared 510(K)
510(k) Number
K013152
510(k) Type
Traditional
Applicant
ELAN HOLDINGS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/9/2001
Days to Decision
50 days
Submission Type
Summary