Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and Abtrol
FDA 510(k) K071580 · Thermofisher Scientific OY
510(k) numberK071580
Submission
- Device name
- Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and Abtrol
- Applicant
- Thermofisher Scientific OY
Vantaa, FI - Received
- June 8, 2007
- Decision date
- October 3, 2007
- 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 |
| 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 |
| 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 |
|---|---|---|
| K110035 | IndikoJJE · Traditional | 06/28/2011SE |
| K073295 | Urea/Bun, Scal, Nortrol, AbtrolCDQ · Traditional | 05/29/2008SE |
| K073612 | Uric Acid (Aox), Scal, Nortrol, AbtrolJIX · Traditional | 05/23/2008SE |
| K073355 | Calcium, Scal, Nortrol, AbtrolCJY · Traditional | 02/28/2008SE |
| K073191 | Alkaline Phosphatase (Ifcc) Plus, Ecal, Nortrol, AbtrolCJE · Traditional | 02/28/2008SE |
| K070824 | Creatinine (Enzymatic)JFY · Traditional | 12/03/2007SE |
| K071340 | Carbon Dioxide (CO2), Scal, Nortrol and AbtrolKHS · Traditional | 10/05/2007SE |
Questions and answers
When was Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and Abtrol cleared by the FDA?
Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and Abtrol (K071580) received a 510(k) decision of Substantially Equivalent on October 3, 2007, 117 days after the submission was received.
What is the product code of K071580?
The FDA product code is CIT – Nadh Oxidation/Nad Reduction, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.