Last synced on 25 November 2022 at 11:04 pm

LUMINELLE DTx System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210512
510(k) Type
Traditional
Applicant
Uvision360, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/30/2021
Days to Decision
127 days
Submission Type
Summary

LUMINELLE DTx System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210512
510(k) Type
Traditional
Applicant
Uvision360, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/30/2021
Days to Decision
127 days
Submission Type
Summary