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ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY

Page Type
Cleared 510(K)
510(k) Number
K050632
510(k) Type
Traditional
Applicant
BAYER HEALTHCARE, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/26/2005
Days to Decision
78 days
Submission Type
Summary

ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY

Page Type
Cleared 510(K)
510(k) Number
K050632
510(k) Type
Traditional
Applicant
BAYER HEALTHCARE, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/26/2005
Days to Decision
78 days
Submission Type
Summary