Clinistat Sgot (Ast) Reagent Test
FDA 510(k) K885156 · Heraeus Kulzer, Inc.
510(k) numberK885156
Submission
- Device name
- Clinistat Sgot (Ast) Reagent Test
- Applicant
- Heraeus Kulzer, Inc.
Elkhart, IN, US - Received
- December 15, 1988
- Decision date
- February 2, 1989
- 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 |
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| K123278 | Ibond Self Etch Bottle Assortment, Ibond Self Etch Bottle Value Pack, Ibond Self Etch…KLE · Special | 12/07/2012SE |
| K120914 | Flexitime Fast & Scan Light FlowELW · Special | 07/25/2012SE |
| K113574 | Flexitime Monophase Pro ScanELW · Traditional | 07/13/2012SE |
| K112501 | Venus Pearl PLT Refill A1EBF · Traditional | 12/14/2011SE |
| K111832 | Paladon Ultra Powder (Pink), Paladon Ultra LiquidEBI · Traditional | 09/29/2011SE |
| K110037 | Palaxpress Ultra Powder (Pink); Palaxpress Ultra LiquidEBI · Traditional | 04/29/2011SE |
| K102770 | Flextime Fast & Scan Putty, Flextime Fast & Scan Light Flow, Flextime Fast & Scan Medium…ELW · Traditional | 12/21/2010SE |
| K101617 | Flexitime Xtreme 2 Heavy Tray Cartridge Refill, Fexitime Xtreme 2 Light Tray Cartridge…ELW · Traditional | 09/07/2010SE |
| K093575 | Gluma Desensitizer Power GelLBH · Traditional | 03/05/2010SE |
Questions and answers
When was Clinistat Sgot (Ast) Reagent Test cleared by the FDA?
Clinistat Sgot (Ast) Reagent Test (K885156) received a 510(k) decision of Substantially Equivalent on February 2, 1989, 49 days after the submission was received.
What is the product code of K885156?
The FDA product code is CIT – Nadh Oxidation/Nad Reduction, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.