Product code JFY
- Device name
- Enzymatic Method, Creatinine
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1225
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252619 | QSCHECK UISACR | Qstag, Inc. | 2026-02-20 |
| K212223 | Atellica CH Enzymatic Creatinine_3 (ECre3) | Siemens Healthcare Diagnostics, Inc. | 2021-11-24 |
| K193649 | Yumizen C1200 Creatinine PAP | HORIBA ABX SAS | 2021-05-10 |
| K182384 | ACR LAB Urine Analysis Test System | Healthy.Io, Ltd. | 2019-07-26 |
| K183555 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2019-02-16 |
| K182038 | URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer | Yd Diagnostics Corporation | 2018-12-10 |
| K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System | Ortho-Clinical Diagnostics, Inc. | 2018-10-30 |
| K161527 | Teco Creatinine Enzymatic Reagent Kit | Teco Diagnostics, Inc. | 2017-07-21 |
| K152835 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | Teco Diagnostics, Inc. | 2016-03-07 |
| K142391 | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) | ACON Laboratories, Inc. | 2014-12-22 |
| K132399 | ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL | Elitechgroup | 2014-01-03 |
| K103376 | ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL | Seppim S.A.S. | 2011-11-18 |
| K110137 | ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN | HORIBA ABX SAS | 2011-08-10 |
| K093458 | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 | Beckman Coulter, Inc. | 2009-12-04 |
| K091742 | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 | Beckman Coulter, Inc. | 2009-08-14 |
| K090330 | DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270 | Siemens Healthcare Diagnostics, Inc. | 2009-05-22 |
| K080073 | S-TEST CREATININE (CRE) | Alfa Wassermann, Inc. | 2008-06-30 |
| K073634 | MULTIGENT CREATININE (ENZYMATIC) ASSAY | SENTINEL CH. SpA | 2008-06-19 |
| K072409 | AFINION ACR AND ACR CONTROL | Axis-Shield Poc AS | 2008-02-12 |
| K073055 | DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 | Dade Behring, Inc. | 2008-01-03 |
| K070824 | CREATININE (ENZYMATIC) | Thermofisher Scientific OY | 2007-12-03 |
| K070727 | ADVIA CHEMISTRY ENZYMATIC CREATININE_2 | Siemens Medical Solutions Diagnostics | 2007-08-03 |
| K070383 | ENZYMATIC CREATININE ASSAY (265 SERIES) | Diagnostic Chemicals , Ltd. | 2007-06-22 |
| K071215 | VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927 | Ortho-Clinical Diagnostics, Inc. | 2007-05-25 |
| K071216 | VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927 | Ortho-Clinical Diagnostics, Inc. | 2007-05-25 |
| K062105 | DIAZYME CREATININE LIQUID REAGENTS ASSAY | Diazyme Laboratories | 2007-04-23 |
| K061412 | THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 | Thermo Electron Corp. | 2007-03-23 |
| K061775 | WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR | Wako Chemicals USA, Inc. | 2007-02-23 |
| K063591 | VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208 | Ortho-Clinical Diagnostics, Inc. | 2006-12-15 |
| K061944 | POLY-CHEM CREATININE | Polymedco, Inc. | 2006-11-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20682607200485 | Mission U120 Smart Urine Analyzer | Acon Laboratories, Inc. | 2026-02-06 |
| 20682607200492 | Mission U120 Smart Urine Analyzer | Acon Laboratories, Inc. | 2026-02-06 |
| 20682607200904 | Mission U120 Touch Urine Analyzer | Acon Laboratories, Inc. | 2026-02-06 |
| 20682607200911 | Mission U120 Touch Urine Analyzer | Acon Laboratories, Inc. | 2026-02-06 |
| 16936983168646 | DrugTect Multi-Drug 14 Drugs Rapid Urine Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2025-02-13 |
| 17290017272471 | Minuteful - kidney test | HEALTHY.IO LTD | 2022-11-01 |
| 20885380175548 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2020-06-30 |
| 20885380175562 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2020-06-30 |
| 10758750031788 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2019-11-13 |
| 10612479197494 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 00630414549132 | Uristix® Reagent Strips | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414549026 | Multistix® 9 SG Reagent Strips | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414549255 | Multistix PRO® 10LS Reagent Strips | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414549262 | Multistix PRO® 10LS Reagent Strips | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414550602 | Albustix® Reagent Strips | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414551142 | Azostix® Reagent Strips | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414571263 | CLINITEK Status® Connector | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414572314 | CLINITEK Status®+ Analyzer | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414578330 | CLINITEK Status® Connector | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414593562 | CLINITEK Advantus® Analyzer | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414549125 | Combistix® Reagent Strips | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414549118 | Hema-Combistix® Reagent Strips | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414549057 | Uristix® 4 Reagent Strips | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414549040 | Multistix® 7 Reagent Strips | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414549033 | Multistix® 8 SG Reagent Strips | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414549019 | Multistix® 9 Reagent Strips | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414548968 | Multistix® 10 SG Reagent Strips | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414479095 | Clinitek AtlasPRO® 12 Reagent PAK for Urine Chemistry | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 08806125680224 | URiSCAN 2 ACR strip | YD Diagnostics CORP. | 2016-08-05 |
| 08806125680231 | URiSCAN 10 ACR strip | YD Diagnostics CORP. | 2016-08-05 |