Stanbio Ast/Got (Liqui-Uv) Test Set, Cat No. 9020
FDA 510(k) K932049 · Stanbio Laboratory
510(k) numberK932049
Submission
- Device name
- Stanbio Ast/Got (Liqui-Uv) Test Set, Cat No. 9020
- Applicant
- Stanbio Laboratory
San Antonio, TX, US - Received
- April 27, 1993
- Decision date
- November 16, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K023551 | Wiener Lab Got (Ast) UV Aa LiquidaCIT · Traditional | Wiener Laboratories Saic | 12/09/2002SE |
| 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 |
More from Elan Holdings, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K090093 | Stanbio Laboratory Hemopoint H2 DM Hemoglobin Measurement SystemGKR · Special | 06/10/2009SE |
| K081719 | Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement SystemGKR · Special | 07/18/2008SE |
| K050283 | Creatinine LiquicolorJFY · Traditional | 06/30/2005SE |
| K050266 | Direct Bilirubin Liquicolor and Total Bilirubin LiquicolorJFM · Traditional | 06/30/2005SE |
| K042169 | Stanbio Laboratory Sirrus Clinical Chemistry AnalyzerJJE · Traditional | 03/14/2005SE |
| K041155 | Wide Range C-Reactive Protein (WR CRP) AssayDCK · Traditional | 10/14/2004SE |
| K032936 | Direct LDL Cholesterol Liquid Color and Stanbio Direct Hdl/Ldl Cholesterol CalibratorJIX · Traditional | 03/12/2004SE |
| K032932 | Direct Hdl-Cholesterol Liquid Color; Direct Hdl/Ldl-Cholesterol CalibratorLBS · Traditional | 03/10/2004SE |
| K032482 | Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement SystemGKR · Traditional | 10/24/2003SE |
| K020378 | Qupid Plus E.R.JHI · Traditional | 06/21/2002SE |
Questions and answers
When was Stanbio Ast/Got (Liqui-Uv) Test Set, Cat No. 9020 cleared by the FDA?
Stanbio Ast/Got (Liqui-Uv) Test Set, Cat No. 9020 (K932049) received a 510(k) decision of Substantially Equivalent on November 16, 1993, 203 days after the submission was received.
What is the product code of K932049?
The FDA product code is CIT – Nadh Oxidation/Nad Reduction, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.