Ast/Got Procedure
FDA 510(k) K861656 · Data Medical Associates, Inc.
510(k) numberK861656
Submission
- Device name
- Ast/Got Procedure
- Applicant
- Data Medical Associates, Inc.
Arlington, TX, US - Received
- April 30, 1986
- Decision date
- May 29, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K993098 | Hdl-C/Ldl-C Calibrator, Model 1913-003JIX · Traditional | 10/08/1999SE |
| K971113 | Dma Triglycerides ProceduresCDT · Traditional | 05/29/1997SE |
| K961919 | Dma Gamma Glutamyltransferase (GGT) ProcedureJPZ · Traditional | 07/01/1996SE |
| K955796 | Iron Calibrator & Calibration Verification SetJJX · Traditional | 02/29/1996SE |
| K955302 | Serum Bicarbonate/Carbon DioxideKHS · Traditional | 02/29/1996SE |
| K955300 | Total Bilirubin ProcedureCIG · Traditional | 12/20/1995SE |
| K952437 | Dma Glucose Hexokinase U.V. ProcedureCFR · Traditional | 10/03/1995SE |
| K946161 | Dma Total Cholesterol ProcedureCHH · Traditional | 08/23/1995SE |
| K946354 | Dma Unsaturated Iron Binding Capacity ProcedureJMO · Traditional | 05/08/1995SE |
| K946355 | Dma Albumin ProcedureCIX · Traditional | 03/01/1995SE |
Questions and answers
When was Ast/Got Procedure cleared by the FDA?
Ast/Got Procedure (K861656) received a 510(k) decision of Substantially Equivalent on May 29, 1986, 29 days after the submission was received.
What is the product code of K861656?
The FDA product code is CIT – Nadh Oxidation/Nad Reduction, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.