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ADVIA CENTAUR HOMOCYSTEINE ASSAY

Page Type
Cleared 510(K)
510(k) Number
K013406
510(k) Type
Traditional
Applicant
BAYER DIAGNOSTICS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/18/2001
Days to Decision
64 days
Submission Type
Summary

ADVIA CENTAUR HOMOCYSTEINE ASSAY

Page Type
Cleared 510(K)
510(k) Number
K013406
510(k) Type
Traditional
Applicant
BAYER DIAGNOSTICS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/18/2001
Days to Decision
64 days
Submission Type
Summary