Radioimmunoassay, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Radioimmunoassay, Inc.” (first 1978, latest 1980), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 28 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | 1 |
| CEE | Radioimmunoassay, Thyroxine-Binding Globulin | 1 | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 | 1 |
| DPB | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep. | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
Review panels
Most recent Radioimmunoassay, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K802135 | TESTOSTERONE RADIOIMMUNOASSY KIT | CDZ | 1980-10-10 | 36 |
| K800107 | FOLLICLE STIMULATING HORMONE | CGJ | 1980-02-13 | 28 |
| K800106 | LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS | CEP | 1980-02-13 | 28 |
| K792539 | TRIIODOTHYRONINE RIA SYSTEM | CDP | 1980-01-16 | 37 |
| K792154 | THYROID STIMULATING HORMONE | JLW | 1979-11-13 | 19 |
| K792153 | DIGOXIN RADIOIMMUNOASSAY SYSTEM | DPB | 1979-11-13 | 18 |
| K792036 | CORTISOL RADIOIMMUNOASSAY SYSTEM | CGR | 1979-10-30 | 19 |
| K780672 | 125 I-T4 RIA REAGENT | CDX | 1978-06-06 | 43 |
| K780671 | 125 I-T3 UPTAKE REAGENT | CEE | 1978-06-06 | 43 |
Recalls
openFDA lists no recalls under a recalling firm named Radioimmunoassay, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Radioimmunoassay, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Radioimmunoassay, Inc.” (first 1978, latest 1980), across 9 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Radioimmunoassay, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Radioimmunoassay, Inc. is 28 days.
Which FDA product codes appear under Radioimmunoassay, Inc.?
The most frequent FDA product codes under this applicant name are CDP (Radioimmunoassay, Total Triiodothyronine, 1); CDX (Radioimmunoassay, Total Thyroxine, 1); CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone, 1).
Next steps
- See all 9 Radioimmunoassay, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDP, Radioimmunoassay, Inc.'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.