CGX — Alkaline Picrate, Colorimetry, Creatinine Class II
FDA product code CGX covers "Alkaline Picrate, Colorimetry, Creatinine", a Class II medical device regulated under 21 CFR 862.1225. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CGX
- Device Class
- Class II
- Regulation Number
- 862.1225
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252206 | nova biomedical corporation | Nova Allegro UACR Assay, Nova Allegro Analyzer | January 9, 2026 |
| K251058 | truvian health | Tru Kidney Health Test Panel; Tru Analyzer | November 26, 2025 |
| K242685 | siemens healthcare diagnostics | Atellica® CH Creatinine_3 (Crea3) | December 4, 2024 |
| K221813 | nova biomedical corporation | Nova Allegro UACR Assay, Nova Allegro Analyzer | November 19, 2024 |
| K210452 | abbott ireland diagnostics division | Creatinine2 | March 22, 2022 |
| K161494 | siemens healthcare diagnostics | Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) | November 15, 2016 |
| K132638 | siemens healthcare diagnostics | DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE | January 27, 2014 |
| K133728 | siemens healthcare diagnostics | DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE | January 24, 2014 |
| K123586 | medica corporation | EASYRA CREATININE REAGENT | May 15, 2013 |
| K110530 | horiba abx | ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PE | April 30, 2012 |
| K083809 | abbott laboratories | CREATININE | April 7, 2009 |
| K072115 | horiba abx | ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, | November 30, 2007 |
| K071277 | beckman coulter | SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS | June 1, 2007 |
| K071283 | beckman coulter | SYNCHRON SYSTEMS CREATININE REAGENT | June 1, 2007 |
| K071280 | beckman coulter | SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS | June 1, 2007 |
| K061193 | abbott laboratories | CREATININE | June 23, 2006 |
| K060935 | beckman coulter | SYNCHRON SYSTEMS CREATININE (CREA) REAGENT | April 28, 2006 |
| K050652 | arkray | SPOTCHEM II CREATININE, AMYLASE & ALP TESTS | April 6, 2005 |
| K040976 | genchem | GENCHEM CREATININE REAGENT | December 27, 2004 |
| K033058 | diamond diagnostics | CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS | January 30, 2004 |