Creatinine
FDA 510(k) K850932 · Dilab, Inc.
510(k) numberK850932
Submission
- Device name
- Creatinine
- Applicant
- Dilab, Inc.
Miami, FL, US - Received
- March 7, 1985
- Decision date
- June 25, 1985
- 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
Other 510(k)s with product code CGX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K862530 | Rapid AS LatexGTQ · Traditional | 04/21/1987SE |
| K850931 | AlbuminCIX · Traditional | 06/26/1985SE |
| K850938 | CholesterolCGO · Traditional | 06/25/1985SE |
| K850936 | Total ProteinsCEK · Traditional | 06/25/1985SE |
| K850934 | PhosphorusCEO · Traditional | 06/25/1985SE |
| K850933 | Uric AcidCDH · Traditional | 06/25/1985SE |
| K850937 | UreaCDW · Traditional | 06/10/1985SE |
| K850935 | ChlorideCHJ · Traditional | 06/10/1985SE |
| K850930 | GlucoseCGE · Traditional | 06/10/1985SE |
| K850929 | CalciumCIC · Traditional | 06/10/1985SE |
Questions and answers
When was Creatinine cleared by the FDA?
Creatinine (K850932) received a 510(k) decision of Substantially Equivalent on June 25, 1985, 110 days after the submission was received.
What is the product code of K850932?
The FDA product code is CGX – Alkaline Picrate, Colorimetry, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.