Radioassay Systems Laboratories, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Radioassay Systems Laboratories, Inc.” (first 1978, latest 1986), across 13 product codes in 1 review panel. Median 510(k) review time under this name: 37 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 |
|---|---|---|---|
| CGR | Radioimmunoassay, Cortisol | 2 | 2 |
| JLS | Radioimmunoassay, Progesterone | 2 | 2 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | 1 |
| CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | 1 |
| CGI | Radioimmunoassay, Estriol | 1 | 1 |
| CHP | Radioimmunoassay, Estradiol | 1 | 1 |
| CIZ | Radioimmunoassay, Androstenedione | 1 | 1 |
| CJM | Radioimmunoassay, Aldosterone | 1 | 1 |
| CKG | Radioimmunoassay, Acth | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
Plus 3 more product codes.
Review panels
- Clinical Chemistry (15)
Most recent Radioassay Systems Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K862204 | RSL (125I) ALDOSTERONE KIT | CJM | 1986-09-25 | 107 |
| K842960 | ANDROSTENEDIONE BY RIA | CIZ | 1984-09-27 | 62 |
| K840886 | HYDROXYPROGESTERONE BY RIA 17A | JLS | 1984-04-18 | 51 |
| K831855 | HATCH KIT | CKG | 1983-07-28 | 49 |
| K802195 | DEHYDROEPIANDROSTERONE SULFATE KIT RIA | JKC | 1980-10-23 | 43 |
| K800126 | RSL (125 L) PROGESTERONE KIT | JLS | 1980-02-13 | 26 |
| K791999 | (125I) TESTOSTERONE KIT | CDZ | 1979-10-30 | 25 |
| K791835 | CORALENT COAT 125I CORTISOL RADIOIMM. | CGR | 1979-09-27 | 10 |
| K791740 | SERUM 11-DESOXYCORTISOL I AS TRACER | JKB | 1979-09-27 | 17 |
| K791728 | RSL'S ASSAY PROCEDURE QUANTITATION | CGI | 1979-09-27 | 28 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Radioassay Systems Laboratories, 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 Radioassay Systems Laboratories, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Radioassay Systems Laboratories, Inc.” (first 1978, latest 1986), across 13 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Radioassay Systems Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Radioassay Systems Laboratories, Inc. is 37 days.
Which FDA product codes appear under Radioassay Systems Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are CGR (Radioimmunoassay, Cortisol, 2); JLS (Radioimmunoassay, Progesterone, 2); CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone, 1).
Next steps
- See all 15 Radioassay Systems Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CGR, Radioassay Systems Laboratories, 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.