This page includes the latest FDA filings for Opko Diagnostics L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3010909452 |
| FEI Number | 3010909452 |
| Name | OPKO Diagnostics, LLC |
| Owner & Operator | OPKO Health, Inc. |
| Contact Address | 4400 Biscayne Boulevard Miami FL 33137 US |
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 4 Constitution Way Suite F Woburn, MA 01801 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
OPKO Diagnostics, LLC [OPKO Health, Inc.] | Sangia Total PSA Test | 2019-02-19 |
| OPKO Diagnostics, LLC. | Sangia Total PSA Test | 2019-01-30 |