Amresco Creatinine Reagents Product #7790, 7791
FDA 510(k) K900666 · American Research Products Co.
510(k) numberK900666
Submission
- Device name
- Amresco Creatinine Reagents Product #7790, 7791
- Applicant
- American Research Products Co.
Solon, OH, US - Received
- February 13, 1990
- Decision date
- April 19, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CGX – Alkaline Picrate, Colorimetry, Creatinine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1225
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K252206 | Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX · Dual Track | Nova Biomedical Corporation | 01/09/2026SE |
| K251058 | Tru Kidney Health Test Panel; Tru AnalyzerCGX · Traditional | Truvian Health | 11/26/2025SE |
| K242685 | Atellica® CH Creatinine_3 (Crea3)CGX · Traditional | Siemens Healthcare Diagnostics, Inc. | 12/04/2024SE |
| K221813 | Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX · Dual Track | Nova Biomedical Corporation | 11/19/2024SE |
| K210452 | Creatinine2CGX · Traditional | Abbott Ireland Diagnostics Division | 03/22/2022SE |
| K161494 | Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)CGX · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/15/2016SE |
| K132638 | Dimension Creatinine (CRE2) Flex Reagent CartridgeCGX · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/27/2014SE |
| K133728 | Dimension Vista Creatinine (CRE2) Flex Reagent CartridgeCGX · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/24/2014SE |
| K123586 | Easyra Creatinine ReagentCGX · Special | Medica Corporation | 05/15/2013SE |
| K110530 | Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P…CGX · Abbreviated | Horiba Abx SAS | 04/30/2012SE |
More from Horiba Abx SAS
| 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 |
| K900571 | Amresco Product Number 7728 (Bilirubin DPD)CIG · Traditional | 04/16/1990SE |
| K900977 | Amresco Inorganic Phosphorus Product #4312500CEO · Traditional | 04/11/1990SE |
| K900394 | Amresco Bun-Kinetic Reagents Products #7583CDQ · Traditional | 04/11/1990SE |
Questions and answers
When was Amresco Creatinine Reagents Product #7790, 7791 cleared by the FDA?
Amresco Creatinine Reagents Product #7790, 7791 (K900666) received a 510(k) decision of Substantially Equivalent on April 19, 1990, 65 days after the submission was received.
What is the product code of K900666?
The FDA product code is CGX – Alkaline Picrate, Colorimetry, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.