Ast
FDA 510(k) K781784 · Gilford Diagnostics
510(k) numberK781784
Submission
- Device name
- Ast
- Applicant
- Gilford Diagnostics
Mchenry, IL, US - Received
- October 19, 1978
- Decision date
- January 3, 1979
- 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 |
|---|---|---|
| K832094 | Bilirubin Calibrators & ControlJIT · Traditional | 08/11/1983SE |
| K831844 | Direct Bilirubin ReagentCIG · Traditional | 07/18/1983SE |
| K831843 | Gilchem Total Bilirubin ReagentCIG · Traditional | 07/18/1983SE |
| K823709 | Triglyceride Reagent (UV)CDT · Traditional | 01/07/1983SE |
| K822739 | AhbdJMK · Traditional | 10/18/1982SE |
| K822334 | Bilirubin CalibratorsJIT · Traditional | 09/02/1982SE |
| K822289 | CO2/CI StandardsJIX · Traditional | 08/24/1982SE |
| K822149 | Gilchem Y-Gt ReagentJPZ · Traditional | 08/12/1982SE |
| K821719 | Ammonia ReagentJIF · Traditional | 06/24/1982SE |
| K820976 | Gil Chem Magnesium ReagentJGJ · Traditional | 04/26/1982SE |
Questions and answers
When was Ast cleared by the FDA?
Ast (K781784) received a 510(k) decision of Substantially Equivalent on January 3, 1979, 76 days after the submission was received.
What is the product code of K781784?
The FDA product code is CIT – Nadh Oxidation/Nad Reduction, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.