Creatinine
FDA 510(k) K771834 · Gamma Enterprises, Inc.
510(k) numberK771834
Submission
- Device name
- Creatinine
- Applicant
- Gamma Enterprises, Inc.
Mchenry, IL, US - Received
- September 21, 1977
- Decision date
- November 3, 1977
- 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 |
|---|---|---|
| K790578 | Gamma Smac ReagentsCIG · Traditional | 05/15/1979SE |
| K780507 | Serum Glutamic-Pyruvic TransaminaseCKC · Traditional | 05/03/1978SE |
| K780506 | Carbon Dioxide ReagentsKMS · Traditional | 05/03/1978SE |
| K780505 | Serum Glutamic-Oxaloacetic-TransaminaseCIT · Traditional | 05/03/1978SE |
| K780504 | Creatine Phosphokinase (CPK)JHS · Traditional | 05/03/1978SE |
| K771843 | Wetting Agents · Traditional | 11/22/1977SE |
| K771836 | Lactate DehydrogenaseCFJ · Traditional | 11/22/1977SE |
| K771832 | ChlorideJFS · Traditional | 11/22/1977SE |
| K771838 | Serum IronJIY · Traditional | 11/03/1977SE |
| K771839 | SodiumJGS · Traditional | 11/02/1977SE |
Questions and answers
When was Creatinine cleared by the FDA?
Creatinine (K771834) received a 510(k) decision of Substantially Equivalent on November 3, 1977, 43 days after the submission was received.
What is the product code of K771834?
The FDA product code is CGX – Alkaline Picrate, Colorimetry, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.