Amresco Bun-Kinetic Reagents Products #7583
FDA 510(k) K900394 · American Research Products Co.
510(k) numberK900394
Submission
- Device name
- Amresco Bun-Kinetic Reagents Products #7583
- Applicant
- American Research Products Co.
Solon, OH, US - Received
- January 29, 1990
- Decision date
- April 11, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1770
- Specialty
- Clinical Chemistry
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203771 | Urea Nitrogen2CDQ · Traditional | Abbott Ireland Diagnostics Division | 05/31/2022SE |
| K140690 | BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I Chemistry AnalyzerCDQ · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 09/02/2014SE |
| K110675 | Easyra Urea Nitrogen and Creatinine ReagentsCDQ · Traditional | Medica Corp. | 04/21/2011SE |
| K073295 | Urea/Bun, Scal, Nortrol, AbtrolCDQ · Traditional | Thermofisher Scientific OY | 05/29/2008SE |
| K070146 | Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPCDQ · Traditional | Horiba Abx | 10/12/2007SE |
| K060120 | Teco CX3 Reagent Set for Synchron CX SystemCDQ · Traditional | Teco Diagnostics | 03/27/2006SE |
| K041051 | Raichem Bun Rate Reagent (Liquid)CDQ · Traditional | Hemagen Diagnostics, Inc. | 06/30/2004SE |
| K024182 | Precision Systems Analette Chemistry Analyzer Stanbio Laboratory ReagentsCDQ · Traditional | Precision Systems, Inc. | 03/03/2003SE |
| K021385 | Atac Pak Bun ReagentCDQ · Traditional | Elan Diagnostics | 07/12/2002SE |
| K012649 | Raichem Bun Rate ReagentCDQ · Traditional | Hemagen Diagnostics, Inc. | 10/15/2001SE |
More from Hemagen Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K942984 | Bun ReagentCDQ · Traditional | 03/01/1995SE |
| K901527 | Biuret (Colormetric), Total ProteinCEK · Traditional | 07/19/1990SE |
| K901964 | Phosphorus Reagents Prod Codes 7763/7764/7563/7463CEO · Traditional | 05/31/1990SE |
| K901960 | Iron Reagents Product Codes 7725 and 7726JMO · Traditional | 05/31/1990SE |
| K900827 | Colorimetric Chloride Product #4314125CHI · Traditional | 05/02/1990SE |
| K901702 | Nad Reduction, Alt/Spgt Codes 7722,7723,7422,7522CKA · Traditional | 04/25/1990SE |
| K900667 | Amresco Ldh-L Reagents Products #7710, 7711CFJ · Traditional | 04/19/1990SE |
| K900666 | Amresco Creatinine Reagents Product #7790, 7791CGX · Traditional | 04/19/1990SE |
| K900571 | Amresco Product Number 7728 (Bilirubin DPD)CIG · Traditional | 04/16/1990SE |
| K900977 | Amresco Inorganic Phosphorus Product #4312500CEO · Traditional | 04/11/1990SE |
Questions and answers
When was Amresco Bun-Kinetic Reagents Products #7583 cleared by the FDA?
Amresco Bun-Kinetic Reagents Products #7583 (K900394) received a 510(k) decision of Substantially Equivalent on April 11, 1990, 72 days after the submission was received.
What is the product code of K900394?
The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.