Wiener Laboratories Saic: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Wiener Laboratories Saic” (first 2001, latest 2004), across 20 product codes in 3 review panels. Median 510(k) review time under this name: 60 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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 2 | 2 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 2 | 2 |
| JFJ | Catalytic Methods, Amylase | 2 | 2 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 2 | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
Plus 10 more product codes.
Review panels
- Clinical Chemistry (22)
- Microbiology (1)
- Clinical Toxicology (1)
Most recent Wiener Laboratories Saic 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023889 | WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 | MIU | 2004-02-11 | 447 |
| K024305 | WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006 | JIX | 2003-03-18 | 84 |
| K024116 | WIENER LAB. BILIRUBINA DIRECT AA | CIG | 2003-02-12 | 61 |
| K023992 | WIENER LAB COLINESTERASA AA | DIH | 2003-02-12 | 72 |
| K023744 | WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 | JHW | 2003-01-03 | 57 |
| K023551 | WIENER LAB GOT (AST) UV AA LIQUIDA | CIT | 2002-12-09 | 48 |
| K023550 | WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA | KNK | 2002-12-09 | 48 |
| K023549 | WIENER LAB AMILASA 405 AA LIQUIDA | JFJ | 2002-12-09 | 48 |
| K022962 | WIENER LAB. BILIRRUBINA TOTAL AA | CIG | 2002-11-01 | 56 |
| K021334 | WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5 | CJY | 2002-09-10 | 137 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Wiener Laboratories Saic.
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.
- Wiener Laboratories (1 510(k)s)
- Wiener Laboratorios Saic (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Wiener Laboratories Saic?
FDA lists 24 510(k) clearances under the applicant name “Wiener Laboratories Saic” (first 2001, latest 2004), across 20 product codes in 3 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 Wiener Laboratories Saic?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wiener Laboratories Saic is 60 days.
Which FDA product codes appear under Wiener Laboratories Saic?
The most frequent FDA product codes under this applicant name are CIG (Diazo Colorimetry, Bilirubin, 2); CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot, 2); JFJ (Catalytic Methods, Amylase, 2).
Next steps
- See all 24 Wiener Laboratories Saic clearances with predicates and recalls
- Run predicate analysis for product code CIG, Wiener Laboratories Saic'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.