510(k) · Cleared
ClearedWiener Lab Got (Ast) UV AA Liquida
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wiener Laboratories Saic · CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
Cleared on Dec 9, 2002 after a 48-day review. The FDA summary names its predicate without a number.
- Decided
- Dec 9, 2002
- Review
- 48 days
- Class
- Class II
- Product code
- CIT
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CIT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Wiener lab. GOT (AST) UV (Cat. NO1751302) Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All CIT devicesCIT Nadh Oxidation/Nad Reduction, Ast/Sgot: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CIT
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · CIT
Too few CIT 510(k)s in any year since 2007 to give a median.
Recalls per year · CIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIT
10in 2025
MAUDE reports naming product code CIT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 23 |
| 2008 | 2 | — | 3 | 17 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 1 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 1 | 2 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The “Wiener lab. GOT (AST) UV AA Liquida” (test system is a
quantitative in vitro diagnostic device intended to be used in the
quantitative determination of aspartate amino transferase (AST or
GOT) in human serum and plasma on both manual and automated
systems. Aspartate amino transferase measurements are used in the
diagnosis and treatment of certain types of liver and heart diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023551 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023551: Wiener Lab Got (Ast) UV AA Liquida.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023551
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026