Wien Laboratories, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Wien Laboratories, Inc.” (first 1977, latest 1991), across 9 product codes in 2 review panels. 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 |
|---|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 2 | 2 |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 2 | 2 |
| JLX | Radioimmunoassay, 17-Hydroxyprogesterone | 2 | 2 |
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | 2 | 2 |
| CGI | Radioimmunoassay, Estriol | 1 | 1 |
| CIY | Radioimmunoassay, Androsterone | 1 | 1 |
| CIZ | Radioimmunoassay, Androstenedione | 1 | 1 |
| DNL | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep. | 1 | 1 |
| DPB | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep. | 1 | 1 |
Review panels
Most recent Wien Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K912850 | SHBG | CDZ | 1991-08-12 | 45 |
| K834246 | PROGESTERONE TEST SET 125I 17-OH | JLX | 1984-02-04 | 59 |
| K832452 | ANDROSTENEDIONE TEST SET 125I | CIZ | 1983-09-12 | 49 |
| K823200 | 125 I-DEHYDROEPIANDROSTERONE SULFATE | JKC | 1982-11-29 | 34 |
| K821653 | PROTRIPTYLINE TRI-CY TEST SET | LFG | 1982-06-14 | 11 |
| K821652 | DOXEPIN TRI-CY TEST SET | LFG | 1982-06-14 | 11 |
| K802728 | 125I-TESTOSTERONE TEST SET | CDZ | 1980-12-11 | 38 |
| K792041 | DHEA-SULFATE TEST SET | JKC | 1979-10-30 | 18 |
| K781834 | TEST SET, 125 I-DIGOXIN | DNL | 1979-01-03 | 65 |
| K781599 | I-ESTRIOL TEST SET | CGI | 1978-10-17 | 29 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Wien 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 Wien Laboratories, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Wien Laboratories, Inc.” (first 1977, latest 1991), 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 Wien Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wien Laboratories, Inc. is 37 days.
Which FDA product codes appear under Wien Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone, 2); JKC (Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate), 2); JLX (Radioimmunoassay, 17-Hydroxyprogesterone, 2).
Next steps
- See all 13 Wien Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDZ, Wien 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.