Creatinine Rate Reagent Kit
FDA 510(k) K811406 · Chem-Elec, Inc.
510(k) numberK811406
Submission
- Device name
- Creatinine Rate Reagent Kit
- Applicant
- Chem-Elec, Inc.
Mchenry, IL, US - Received
- May 19, 1981
- Decision date
- August 13, 1981
- 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 |
|---|---|---|
| K943503 | Chemcard Glucose TestCGA · Traditional | 07/23/1996SE |
| K864159 | Solid Phase Deter Serum Cholesterol FR Whole BloodCHH · Traditional | 06/10/1988SE |
| K811381 | AstraJFL · Traditional | 08/13/1981SE |
| K811319 | Chloride Reagent KitJFS · Traditional | 08/13/1981SE |
| K811165 | Glucose Oxidase Rate ReagentCGA · Traditional | 08/13/1981SE |
| K811310 | Sodium/Potassium Reagent KitsCEM · Traditional | 07/10/1981SE |
| K811193 | Bun Rate ReagentCDS · Traditional | 07/10/1981SE |
| K811701 | Chloride/Carbon Dioxide Rate ReagentJFS · Traditional | 07/01/1981SE |
Questions and answers
When was Creatinine Rate Reagent Kit cleared by the FDA?
Creatinine Rate Reagent Kit (K811406) received a 510(k) decision of Substantially Equivalent on August 13, 1981, 86 days after the submission was received.
What is the product code of K811406?
The FDA product code is CGX – Alkaline Picrate, Colorimetry, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.