Hichem Ast Reagent Kit
FDA 510(k) K951751 · Hichem Diagnostics
510(k) numberK951751
Submission
- Device name
- Hichem Ast Reagent Kit
- Applicant
- Hichem Diagnostics
Brea, CA, US - Received
- April 17, 1995
- Decision date
- August 2, 1995
- 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 |
| 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 |
|---|---|---|
| K981794 | Hichem Calcium Reagent KitCJY · Traditional | 07/29/1998SE |
| K963383 | Hichem Alp/Amp Reagent KitCKF · Traditional | 09/23/1996SE |
| K953863 | Hichem Ise Standards Kit 70011JIX · Traditional | 09/06/1995SE |
| K953862 | Hichem Isekci Solution Kit 70010CGZ · Traditional | 09/06/1995SE |
| K953861 | Hichem Ise Intdernal Reference Kit 70009CGZ · Traditional | 09/06/1995SE |
| K953860 | Hichem Ise Diluent Kit 70008CGZ · Traditional | 09/06/1995SE |
| K946192 | Hichem Y-Gt Reagent KitJQB · Traditional | 05/02/1995SE |
| K946022 | Hichem Ldh/L Reagent KitCFJ · Traditional | 02/23/1995SE |
| K941433 | Hi Chem Aqueous Glucose Control, Low, Med, HighJJX · Traditional | 08/02/1994SE |
| K925612 | Hi Chem Electrolyte BufferJGS · Traditional | 04/20/1993SE |
Questions and answers
When was Hichem Ast Reagent Kit cleared by the FDA?
Hichem Ast Reagent Kit (K951751) received a 510(k) decision of Substantially Equivalent on August 2, 1995, 107 days after the submission was received.
What is the product code of K951751?
The FDA product code is CIT – Nadh Oxidation/Nad Reduction, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.