Ria Diagnostics: FDA clearances and approvals
Ria Diagnostics has 7 FDA 510(k) clearances (first 1978, latest 1986), across 7 product codes in 3 review panels. Median 510(k) review time: 38 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| DDQ | Antigen, Antiserum, Control, Antithrombin Iii | 1 | 1 |
| DON | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep. | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 | 1 |
| LCA | Radioimmunoassay, Theophylline | 1 | 1 |
Review panels
- Clinical Chemistry (4)
- Clinical Toxicology (2)
- Hematology (1)
Most recent Ria Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K855033 | T-3 UPTAKE/RIASSAY | KHQ | 1986-01-24 | 38 |
| K854798 | T-4 RIASSAY | CDX | 1986-01-15 | 44 |
| K852537 | T-3 RIASSAY | CDP | 1985-08-12 | 59 |
| K810296 | DIGOXIN RIA ASSAY | DON | 1981-02-19 | 15 |
| K801691 | TSH RIASSAY | JLW | 1980-08-27 | 35 |
| K792062 | THEOPHYLLINE RIASSAY | LCA | 1980-02-25 | 133 |
| K780012 | ANTITHROMBIN III RIA | DDQ | 1978-01-20 | 17 |
Recalls
openFDA lists no recalls under a recalling firm named Ria Diagnostics.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Ria Diagnostics's product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Ria Diagnostics have?
Ria Diagnostics has 7 FDA 510(k) clearances (first 1978, latest 1986), across 7 product codes in 3 review panels.
How long does FDA take to clear Ria Diagnostics's 510(k)s?
The median time from FDA receipt to decision across Ria Diagnostics's cleared 510(k)s is 38 days.
What devices does Ria Diagnostics make?
Its most frequent FDA product codes are CDP (Radioimmunoassay, Total Triiodothyronine, 1); CDX (Radioimmunoassay, Total Thyroxine, 1); DDQ (Antigen, Antiserum, Control, Antithrombin Iii, 1).
Has Ria Diagnostics had device recalls?
openFDA lists no recalls under a recalling firm name matching Ria Diagnostics. Related entities may recall under other names.
Next steps
- See all 7 Ria Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code CDP, Ria Diagnostics's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.