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BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230956
510(k) Type
Traditional
Applicant
BD Integrated Diagnostic Solutions/
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/31/2023
Days to Decision
118 days
Submission Type
Summary

BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230956
510(k) Type
Traditional
Applicant
BD Integrated Diagnostic Solutions/
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/31/2023
Days to Decision
118 days
Submission Type
Summary