Ast (Sgot)
FDA 510(k) K013698 · Jas Diagnostics, Inc.
510(k) numberK013698
Submission
- Device name
- Ast (Sgot)
- Applicant
- Jas Diagnostics, Inc.
Miami, FL, US - Received
- November 7, 2001
- Decision date
- December 21, 2001
- 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 |
| 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 |
|---|---|---|
| K130915 | XL-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent PackJJE · Traditional | 05/15/2014SE |
| K080623 | Cholesterol Oxidase Jase, and Glycerol Inase Triglycerides, Model NaCHH · Traditional | 11/17/2008SE |
| K080618 | Direct HBA1C, Fructosamine, Glucose Oxidase LiquidLCP · Traditional | 05/23/2008SE |
| K022519 | LDL Cholesterol (Automated)JHM · Traditional | 09/30/2002SE |
| K021671 | Jas HDL Cholesterol (Automated) ReagentLBS · Traditional | 07/19/2002SE |
| K020454 | Chemistry CalibratorJIT · Traditional | 04/08/2002SE |
| K020282 | Jas Amylase Liquid ReagentJFJ · Traditional | 02/28/2002SE |
| K013912 | Creatine Kinase (Ck-Nac)CGS · Traditional | 01/18/2002SE |
| K012332 | Jas Carbon Dioxide Liquid ReagentKHS · Traditional | 09/06/2001SE |
| K012038 | Jas Uric Acid Liquid ReagentKNK · Traditional | 08/21/2001SE |
Questions and answers
When was Ast (Sgot) cleared by the FDA?
Ast (Sgot) (K013698) received a 510(k) decision of Substantially Equivalent on December 21, 2001, 44 days after the submission was received.
What is the product code of K013698?
The FDA product code is CIT – Nadh Oxidation/Nad Reduction, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.