Ast/Sgot
FDA 510(k) K991663 · A.P. Total Care, Inc.
510(k) numberK991663
Submission
- Device name
- Ast/Sgot
- Applicant
- A.P. Total Care, Inc.
Bridgeport, CT, US - Received
- May 14, 1999
- Decision date
- June 30, 1999
- 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 |
|---|---|---|
| K991246 | Fructosamine, Model FR 106-01LCP · Traditional | 12/16/1999SE |
| K991762 | Alkaline Phophatase (Alp), Product No's 118-01, 118-02CJE · Traditional | 09/02/1999SE |
| K991761 | Magnesium Product No's, 112-01, 112-02JGJ · Traditional | 09/02/1999SE |
| K991664 | LDL Cholesterol, Product No's, 124-01, CH102-01LBS · Traditional | 08/19/1999SE |
| K991665 | HDL Cholesterol, Product No's 124-01, CH102-01LBS · Traditional | 08/10/1999SE |
| K991867 | Inorganic Phosphorus (Ip), Product No's, 112-01, 112-02CEO · Traditional | 08/02/1999SE |
| K991866 | Bilirubin, Total and Direct, Product No, 122-01, 122-02, 122-03, 122-04CIG · Traditional | 08/02/1999SE |
| K991870 | Electrolytes (Na+, K+, Cl-), Product No's 114-01, 114-02, 114-03CGZ · Traditional | 07/30/1999SE |
| K991666 | Tibc, Product No's 123-0, 123-02, FE109-01, FE109-02JMO · Traditional | 06/30/1999SE |
| K991247 | Uric Acid, Model UA112-01KNK · Traditional | 05/25/1999SE |
Questions and answers
When was Ast/Sgot cleared by the FDA?
Ast/Sgot (K991663) received a 510(k) decision of Substantially Equivalent on June 30, 1999, 47 days after the submission was received.
What is the product code of K991663?
The FDA product code is CIT – Nadh Oxidation/Nad Reduction, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.