Ultrazyme Plus Got
FDA 510(k) K780103 · Harleco
510(k) numberK780103
Submission
- Device name
- Ultrazyme Plus Got
- Applicant
- Harleco
Mchenry, IL, US - Received
- January 20, 1978
- Decision date
- February 13, 1978
- 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 |
|---|---|---|
| K820233 | Ultrazyme Plus Gamma GT(65055-65056)JQB · Traditional | 02/12/1982SE |
| K813427 | Ultrachem Gluc-DhLFR · Traditional | 12/31/1981SE |
| K813044 | Ultrachem Alb, Item #64970CIX · Traditional | 11/10/1981SE |
| K813043 | Ultrachem Crea Item #64972CGX · Traditional | 11/10/1981SE |
| K813042 | Ultrachem Gluc-Dh Set, Item #65048LFR · Traditional | 11/10/1981SE |
| K813041 | Ultrazyme-Gt, Item #64959 & 65032JQB · Traditional | 11/10/1981SE |
| K813040 | Ultrachem Ca, Item #64975CJY · Traditional | 11/10/1981SE |
| K813039 | Ultrachem E-Chol, Item #65025CHH · Traditional | 11/10/1981SE |
| K813038 | Ultrachem TP, Item #64974CEK · Traditional | 11/10/1981SE |
| K812594 | Ultra Zyme Plus Amyl #64982 & 65031CIJ · Traditional | 10/02/1981SE |
Questions and answers
When was Ultrazyme Plus Got cleared by the FDA?
Ultrazyme Plus Got (K780103) received a 510(k) decision of Substantially Equivalent on February 13, 1978, 24 days after the submission was received.
What is the product code of K780103?
The FDA product code is CIT – Nadh Oxidation/Nad Reduction, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.