Ast/Sgot
FDA 510(k) K965126 · Derma Media Lab., Inc.
510(k) numberK965126
Submission
- Device name
- Ast/Sgot
- Applicant
- Derma Media Lab., Inc.
Santa Fe Springs, CA, US - Received
- December 23, 1996
- Decision date
- January 17, 1997
- 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 |
|---|---|---|
| K971309 | UreaCDQ · Traditional | 08/01/1997SE |
| K970664 | Glucose ReagentCFR · Traditional | 08/01/1997SE |
| K971072 | Cholesterol ReagentCHH · Traditional | 06/20/1997SE |
| K971005 | TriglyceridesJGY · Traditional | 04/21/1997SE |
| K970867 | Uric Acid ReagentKNK · Traditional | 04/21/1997SE |
| K964915 | MagnesiumJGJ · Traditional | 03/26/1997SE |
| K964913 | Iron ReagentJIY · Traditional | 02/20/1997SE |
| K965134 | Alt/SgptCKA · Traditional | 02/18/1997SE |
| K964914 | Alkaline PhosphataseCJE · Traditional | 02/04/1997SE |
| K964916 | Gamma-Glutamyl TranspeptidaseJQB · Traditional | 01/10/1997SE |
Questions and answers
When was Ast/Sgot cleared by the FDA?
Ast/Sgot (K965126) received a 510(k) decision of Substantially Equivalent on January 17, 1997, 25 days after the submission was received.
What is the product code of K965126?
The FDA product code is CIT – Nadh Oxidation/Nad Reduction, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.