Last synced on 6 December 2024 at 11:05 pm

binx health io CT/NG Assay

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191352
510(k) Type
Traditional
Applicant
binx health, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/8/2019
Days to Decision
80 days
Submission Type
Summary

binx health io CT/NG Assay

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191352
510(k) Type
Traditional
Applicant
binx health, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/8/2019
Days to Decision
80 days
Submission Type
Summary