Wiener Lab Got (Ast) UV Aa Liquida
FDA 510(k) K023551 · Wiener Laboratories Saic
510(k) numberK023551
Submission
- Device name
- Wiener Lab Got (Ast) UV Aa Liquida
- Applicant
- Wiener Laboratories Saic
Rosario, Santa Fe, AR - Received
- October 22, 2002
- Decision date
- December 9, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CIT – Nadh Oxidation/Nad Reduction, Ast/Sgot
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1100
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K093883 | Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model ASSL-0250…CIT · Traditional | Seppim S.A.S. | 09/20/2010SE |
| K080485 | Aspartate Amino Transferase (Ast/Sgot) Test System, Asat (Got) FSCIT · Traditional | Diasys Diagnostics Systems GmbH | 12/04/2008SE |
| K071525 | Activated Aspartate AminotransferaseCIT · Traditional | Abbott Laboratories | 03/19/2008SE |
| K071580 | Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and AbtrolCIT · Traditional | Thermofisher Scientific OY | 10/03/2007SE |
| K071211 | Cobas C 111 AnalyzerCIT · Traditional | Roche Diagnostics | 07/30/2007SE |
| K060318 | Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry AnalyzerCIT · Traditional | Horiba Abx | 08/08/2006SE |
| K013698 | Ast (Sgot)CIT · Traditional | Jas Diagnostics, Inc. | 12/21/2001SE |
| K013145 | Wiener Lab. Got (Ast) UV Aa. Weiner Lab. Got (Ast) UV Unitest, Models 10 * 20 ML Cat.…CIT · Traditional | Wiener Laboratories Saic | 11/27/2001SE |
| K010488 | Atac Pak Ast Reagent KitCIT · Traditional | Elan Holdings, Inc. | 04/09/2001SE |
| K001679 | Vitros Chemistry Products Ast Slide and Chemistry Products Calibrator Kit 3CIT · Special | Ortho-Clinical Diagnostics, Inc. | 06/28/2000SE |
More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K023889 | Wiener Lab. Chagatest Elisa Recomninante V.3.0, Model 96 Tests Cat. Nr. 1203254MIU · Traditional | 02/11/2004SE |
| K024305 | Wiener Lab. Calibrator a Plus, Model 2X3 ML Cat. Nr. 1918006JIX · Traditional | 03/18/2003SE |
| K024116 | Wiener Lab. Bilirubina Direct AaCIG · Traditional | 02/12/2003SE |
| K023992 | Wiener Lab Colinesterasa AaDIH · Traditional | 02/12/2003SE |
| K023744 | Wiener Lab. Ck-Mb DS UV Unitest, Model 28 X 2.5 ML Cat. Nr. 1271354JHW · Traditional | 01/03/2003SE |
| K023550 | Wiener Lab Uricostat Enzimatico Aa LiquidaKNK · Traditional | 12/09/2002SE |
| K023549 | Wiener Lab Amilasa 405 Aa LiquidaJFJ · Traditional | 12/09/2002SE |
| K022962 | Wiener Lab. Bilirrubina Total AaCIG · Traditional | 11/01/2002SE |
| K021334 | Wiener Lab. Ca-Color Arsenazo III Aa, Model 4X50 ML Cat.Nr. 1152004, Wiener Lab.Ca-Color…CJY · Traditional | 09/10/2002SE |
| K021332 | Wiener Lab. Ck-Nac UV Unitest, Wiener Lab. Ck-Nac UV Aa, Wiener Lab. Ck-Nac UV Aa…CGS · Traditional | 07/03/2002SE |
Questions and answers
When was Wiener Lab Got (Ast) UV Aa Liquida cleared by the FDA?
Wiener Lab Got (Ast) UV Aa Liquida (K023551) received a 510(k) decision of Substantially Equivalent on December 9, 2002, 48 days after the submission was received.
What is the product code of K023551?
The FDA product code is CIT – Nadh Oxidation/Nad Reduction, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.