Ast-Uv (Plp-Activated) Determination
FDA 510(k) K810727 · The Dow Chemical Co.
510(k) numberK810727
Submission
- Device name
- Ast-Uv (Plp-Activated) Determination
- Applicant
- The Dow Chemical Co.
Mchenry, IL, US - Received
- March 17, 1981
- Decision date
- March 31, 1981
- 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 |
|---|---|---|
| K823474 | Enzymatic Glucose DeterminationCGA · Traditional | 12/30/1982SE |
| K822154 | Urea Nitrogen (Enzymatic) DeterminationCDN · Traditional | 08/05/1982SE |
| K821536 | Dowflow Alt-Uv DeterminationCKA · Traditional | 06/14/1982SE |
| K821315 | Dowflow Enzymatic Triglycerides DetermCDT · Traditional | 05/24/1982SE |
| K820714 | Dow Bilirubin(Direct) DeterminationCIG · Traditional | 04/01/1982SE |
| K820675 | Bilirubin(Total) Determination CTMSCIG · Traditional | 04/01/1982SE |
| K812777 | Direct Iron Reagent SetJIY · Traditional | 10/19/1981SE |
| K811806 | Quick-Chem ColorimeterJJQ · Traditional | 07/15/1981SE |
| K810861 | Creatine Kinase MB Isoenzyme Immuno UVJHW · Traditional | 04/14/1981SE |
| K801501 | UV Uric Acid StandardsJIS · Traditional | 09/26/1980SE |
Questions and answers
When was Ast-Uv (Plp-Activated) Determination cleared by the FDA?
Ast-Uv (Plp-Activated) Determination (K810727) received a 510(k) decision of Substantially Equivalent on March 31, 1981, 14 days after the submission was received.
What is the product code of K810727?
The FDA product code is CIT – Nadh Oxidation/Nad Reduction, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.