Ast )Got) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST)
FDA 510(k) K980030 · Trace America, Inc.
510(k) numberK980030
Submission
- Device name
- Ast )Got) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST)
- Applicant
- Trace America, Inc.
Miami, FL, US - Received
- January 5, 1998
- Decision date
- January 30, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K010488 | Atac Pak Ast Reagent KitCIT · Traditional | Elan Holdings, Inc. | 04/09/2001SE |
More from Elan Holdings, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K003583 | Lithium Regent Model TR66056 / Lithium Standard TR66901NDW · Traditional | 01/17/2001SE |
| K980026 | Glucose (HK) - Incorporating Dynamic Stabilization Technology - (DST)CFR · Traditional | 03/10/1998SE |
| K980028 | Alt (GPT) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST)CKA · Traditional | 02/02/1998SE |
| K973869 | Trace Reagent Line for the Cobas MiraCKA · Traditional | 01/07/1998SE |
| K974620 | Ammonia-Incorporating Dynamic Stabilization Technology (DST)JIF · Traditional | 01/02/1998SE |
| K972297 | Amylase-Incorporating Dynamic Stabilization Technology - (DST)JFJ · Traditional | 07/17/1997SE |
| K971485 | Uric Acid - Incorporating Dynamic Stabilization Technology - (DST)CDO · Traditional | 05/27/1997SE |
| K971477 | Urea (Urea Nitrogen) - Incorporating Dynamic Stabilization Technology (DST)CDQ · Traditional | 05/27/1997SE |
| K962723 | Trace HDL Cholesterol - Automated (HomogenLBR · Traditional | 03/13/1997SE |
| K961984 | Porphobilinogen (PBG)JNF · Traditional | 12/10/1996SE |
Questions and answers
When was Ast )Got) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST) cleared by the FDA?
Ast )Got) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST) (K980030) received a 510(k) decision of Substantially Equivalent on January 30, 1998, 25 days after the submission was received.
What is the product code of K980030?
The FDA product code is CIT – Nadh Oxidation/Nad Reduction, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.