Emds Aspartate Aminotransferase Item Number 65405
FDA 510(k) K893692 · Diagnostic Systems
510(k) numberK893692
Submission
- Device name
- Emds Aspartate Aminotransferase Item Number 65405
- Applicant
- Diagnostic Systems
Gibbstown, NJ, US - Received
- May 16, 1989
- Decision date
- August 21, 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 |
|---|---|---|
| K905146 | Olympus Urine PHJQY · Traditional | 02/04/1991SE |
| K893691 | Emds Creatine Kinase Item Nimber 65411CGS · Traditional | 08/31/1989SE |
| K893966 | HDL Precipitating ReagentLBR · Traditional | 07/25/1989SE |
| K884993 | Visual Blood Glucose Test SystemCGA · Traditional | 12/29/1988SE |
| K881116 | Easy-Test Emit(R) Lidocaine Lido Item No. 16641KLR · Traditional | 06/20/1988SE |
| K880787 | Easy-Test Lactic Acid (la)KHP · Traditional | 03/15/1988SE |
| K862403 | Emds Antiepileptic Drug Calibrators Item #67630/95DKB · Traditional | 07/11/1986SE |
| K854784 | Absorbance (Abs) Test PakJIT · Traditional | 12/19/1985SE |
| K853699 | Easy Analyzer & Easy-Test ReagentJJE · Traditional | 09/25/1985SE |
| K853533 | Absorbance Test SolutionJIT · Traditional | 09/16/1985SE |
Questions and answers
When was Emds Aspartate Aminotransferase Item Number 65405 cleared by the FDA?
Emds Aspartate Aminotransferase Item Number 65405 (K893692) received a 510(k) decision of Substantially Equivalent on August 21, 1989, 97 days after the submission was received.
What is the product code of K893692?
The FDA product code is CIT – Nadh Oxidation/Nad Reduction, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.