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TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM

Page Type
Cleared 510(K)
510(k) Number
K053020
510(k) Type
Traditional
Applicant
BAYER HEALTHCARE, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/30/2005
Days to Decision
65 days
Submission Type
Summary

TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM

Page Type
Cleared 510(K)
510(k) Number
K053020
510(k) Type
Traditional
Applicant
BAYER HEALTHCARE, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/30/2005
Days to Decision
65 days
Submission Type
Summary