Sgot-Uv Reagent Set
FDA 510(k) K841066 · Medical Specialties, Inc.
510(k) numberK841066
Submission
- Device name
- Sgot-Uv Reagent Set
- Applicant
- Medical Specialties, Inc.
Mchenry, IL, US - Received
- March 12, 1984
- Decision date
- May 1, 1984
- 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 |
|---|---|---|
| K946201 | Stand, InfusionFOX · Traditional | 04/18/1995SE |
| K931947 | CheckpointJPK · Traditional | 06/18/1993SE |
| K926095 | Refractrol-SpJJX · Traditional | 01/26/1993SE |
| K924926 | Msi-HctGLK · Traditional | 01/07/1993SE |
| K896566 | Modified Fox Extra Gram Negative and PositiveJWY · Traditional | 02/09/1990SE |
| K883851 | Msi-Cal 8KRZ · Traditional | 11/22/1988SE |
| K883850 | Msi-Cal 16KRZ · Traditional | 11/22/1988SE |
| K883703 | Msi-Cal 7KRZ · Traditional | 11/22/1988SE |
| K880608 | Msi-PcGJP · Traditional | 03/21/1988SE |
| K880270 | Msi-Diff PlusJPK · Traditional | 03/01/1988SE |
Questions and answers
When was Sgot-Uv Reagent Set cleared by the FDA?
Sgot-Uv Reagent Set (K841066) received a 510(k) decision of Substantially Equivalent on May 1, 1984, 50 days after the submission was received.
What is the product code of K841066?
The FDA product code is CIT – Nadh Oxidation/Nad Reduction, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.