Last synced on 16 May 2025 at 11:05 pm

Alere NT-proBNP for Alinity i Reagent Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K241176
510(k) Type
Traditional
Applicant
Axis-Shield Diagnostics Ltd
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
1/16/2025
Days to Decision
262 days
Submission Type
Summary

Alere NT-proBNP for Alinity i Reagent Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K241176
510(k) Type
Traditional
Applicant
Axis-Shield Diagnostics Ltd
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
1/16/2025
Days to Decision
262 days
Submission Type
Summary