JFY — Enzymatic Method, Creatinine Class II
FDA product code JFY covers "Enzymatic Method, 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
- JFY
- 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 |
|---|---|---|---|
| K252619 | qstag | QSCHECK UISACR | February 20, 2026 |
| K212223 | siemens healthcare diagnostics | Atellica CH Enzymatic Creatinine_3 (ECre3) | November 24, 2021 |
| K193649 | horiba abx | Yumizen C1200 Creatinine PAP | May 10, 2021 |
| K182384 | healthy.io | ACR LAB Urine Analysis Test System | July 26, 2019 |
| K183555 | instrumentation laboratory | GEM Premier ChemSTAT | February 16, 2019 |
| K182038 | yd diagnostics corporation | URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer | December 10, 2018 |
| K182063 | ortho-clinical diagnostics | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VI | October 30, 2018 |
| K161527 | teco diagnostics | Teco Creatinine Enzymatic Reagent Kit | July 21, 2017 |
| K152835 | teco diagnostics | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | March 7, 2016 |
| K142391 | acon laboratories | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbu | December 22, 2014 |
| K132399 | elitechgroup | ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, | January 3, 2014 |
| K103376 | seppim | ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYST | November 18, 2011 |
| K110137 | horiba abx | ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, A | August 10, 2011 |
| K093458 | beckman coulter | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 | December 4, 2009 |
| K091742 | beckman coulter | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 | August 14, 2009 |
| K090330 | siemens healthcare diagnostics | DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREAT | May 22, 2009 |
| K080073 | alfa wassermann | S-TEST CREATININE (CRE) | June 30, 2008 |
| K073634 | sentinel ch | MULTIGENT CREATININE (ENZYMATIC) ASSAY | June 19, 2008 |
| K072409 | axis-shield poc | AFINION ACR AND ACR CONTROL | February 12, 2008 |
| K073055 | dade behring | DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 | January 3, 2008 |