Atac Pak Ast Reagent Kit
FDA 510(k) K010488 · Elan Holdings, Inc.
510(k) numberK010488
Submission
- Device name
- Atac Pak Ast Reagent Kit
- Applicant
- Elan Holdings, Inc.
Brea, CA, US - Received
- February 20, 2001
- Decision date
- April 9, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| 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 |
|---|---|---|
| K013152 | Atac Pak Direct HDL Reagent and Atac Direct HDL Calibrator KitsLBS · Traditional | 11/09/2001SE |
| K012474 | Atac Pak CPK Reagent KitCGS · Traditional | 10/03/2001SE |
| K000958 | Atac Pak Bun Reagent and Atac Calibrator KitsCDQ · Traditional | 05/24/2000SE |
| K000900 | Atac Pak Cholesterol Reagent and Atac Callibrator KitsCHH · Traditional | 05/02/2000SE |
| K992844 | Hichem Ise Electrolyte BufferJGS · Traditional | 11/26/1999SE |
| K992842 | Hichem Ise Electrolyte ReferenceJGS · Traditional | 11/26/1999SE |
| K992846 | Hichem Total Protein ReagentCEK · Traditional | 10/18/1999SE |
| K992845 | Hichem Calibrator 1 Kit, Hichem Calibrator 2 Kit, Hichem Calibrator 3 Kit, Calibration…JIX · Traditional | 10/18/1999SE |
| K992847 | Hichem Bun ReagentLFP · Traditional | 10/14/1999SE |
| K991789 | Atac-Pak Direct HDL Cholesterol Reagent and Atac Hdl-C Calibrator KitsLBR · Traditional | 07/09/1999SE |
Questions and answers
When was Atac Pak Ast Reagent Kit cleared by the FDA?
Atac Pak Ast Reagent Kit (K010488) received a 510(k) decision of Substantially Equivalent on April 9, 2001, 48 days after the submission was received.
What is the product code of K010488?
The FDA product code is CIT – Nadh Oxidation/Nad Reduction, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.