Last synced on 16 May 2025 at 11:05 pm

ST AIA-PACK BNP Assay

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211199
510(k) Type
Special
Applicant
Tosoh Bioscience, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/8/2021
Days to Decision
200 days
Submission Type
Summary

ST AIA-PACK BNP Assay

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211199
510(k) Type
Special
Applicant
Tosoh Bioscience, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/8/2021
Days to Decision
200 days
Submission Type
Summary