Opko Diagnostics, LLC: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Opko Diagnostics, LLC”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MTF | Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer | 1 | 0 |
Review panels
- Immunology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P170037 | PMA | Sangia Total PSA Test | 2019-01-30 |
Recalls
openFDA lists no recalls under a recalling firm named Opko Diagnostics, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Opko Health, Inc. (1 510(k)s)
- Opko Instrumentation, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Opko Diagnostics, LLC?
FDA lists 0 510(k) clearances under the applicant name “Opko Diagnostics, LLC”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Opko Diagnostics, LLC?
The most frequent FDA product codes under this applicant name are MTF (Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer, 1).
Next steps
- See all 0 Opko Diagnostics, LLC clearances with predicates and recalls
- Run predicate analysis for product code MTF, Opko Diagnostics, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.