Ultraviolet Aspartate Amino-Trans (Uv-Ast/Uv-Got)
FDA 510(k) K871780 · Biochemical Trade, Inc.
510(k) numberK871780
Submission
- Device name
- Ultraviolet Aspartate Amino-Trans (Uv-Ast/Uv-Got)
- Applicant
- Biochemical Trade, Inc.
Miami, FL, US - Received
- May 6, 1987
- Decision date
- June 4, 1987
- 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 |
|---|---|---|
| K942958 | Creatine Kinase MB Determination (UV)JHW · Traditional | 11/21/1994SE |
| K910635 | Total Bilirubin Reagent SetCIG · Traditional | 05/15/1991SE |
| K910296 | Phosphorus (Inorganic) Test SystemCEO · Traditional | 02/27/1991SE |
| K905776 | Albumin Reagent SetCJW · Traditional | 02/26/1991SE |
| K905790 | Total Protein Reagent SetCEK · Traditional | 02/21/1991SE |
| K905650 | Kinetic Alkaline Phosphatase DeterminationCJE · Traditional | 02/13/1991SE |
| K905619 | Creatinine (Rate) Reagent SetCGX · Traditional | 02/13/1991SE |
| K905651 | Kinetic Amylase DeterminationJFJ · Traditional | 01/31/1991SE |
| K905649 | Gamma-Glutamyl Transferase DeterminationJQB · Traditional | 01/30/1991SE |
| K905588 | Creatine Kinase UV Reagent SetJHW · Traditional | 01/17/1991SE |
Questions and answers
When was Ultraviolet Aspartate Amino-Trans (Uv-Ast/Uv-Got) cleared by the FDA?
Ultraviolet Aspartate Amino-Trans (Uv-Ast/Uv-Got) (K871780) received a 510(k) decision of Substantially Equivalent on June 4, 1987, 29 days after the submission was received.
What is the product code of K871780?
The FDA product code is CIT – Nadh Oxidation/Nad Reduction, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.