FDA 510(k) Applications for Medical Device Product Code "JFY"
(Enzymatic Method, Creatinine)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K142391 | ACON LABORATORIES, INC. | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) | 12/22/2014 |
| K080073 | ALFA WASSERMANN, INC. | S-TEST CREATININE (CRE) | 06/30/2008 |
| K072409 | AXIS-SHIELD POC AS | AFINION ACR AND ACR CONTROL | 02/12/2008 |
| K021428 | BAYER CORP. | CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM | 07/05/2002 |
| K091742 | BECKMAN COULTER, INC. | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 | 08/14/2009 |
| K093458 | BECKMAN COULTER, INC. | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 | 12/04/2009 |
| K073055 | DADE BEHRING, INC. | DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 | 01/03/2008 |
| K070383 | DIAGNOSTIC CHEMICALS LTD. | ENZYMATIC CREATININE ASSAY (265 SERIES) | 06/22/2007 |
| K030035 | DIAMETRICS MEDICAL, INC. | IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE | 06/25/2003 |
| K062105 | DIAZYME LABORATORIES | DIAZYME CREATININE LIQUID REAGENTS ASSAY | 04/23/2007 |
| K132399 | ELITECH GROUP | ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL | 01/03/2014 |
| K980043 | EXIGENT DIAGNOSTICS, INC. | CARESIDE CREATININE | 03/30/1998 |
| K182384 | Healthy.io Ltd | ACR LAB Urine Analysis Test System | 07/26/2019 |
| K110137 | HORIBA ABX S.A.S. | ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN | 08/10/2011 |
| K193649 | Horiba ABX SAS | Yumizen C1200 Creatinine PAP | 05/10/2021 |
| K183555 | Instrumentation Laboratory Co. | GEM Premier ChemSTAT | 02/16/2019 |
| K984530 | METRIKA, INC. | DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE | 08/10/1999 |
| K001310 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 | 05/05/2000 |
| K182063 | Ortho-Clinical Diagnostics, Inc. | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System | 10/30/2018 |
| K063591 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208 | 12/15/2006 |
| K071216 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927 | 05/25/2007 |
| K071215 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927 | 05/25/2007 |
| K061944 | POLYMEDCO, INC. | POLY-CHEM CREATININE | 11/03/2006 |
| K010456 | POLYMER TECHNOLOGY SYSTEMS, INC. | BIOSCANNER CREATININE TEST STRIPS | 06/20/2001 |
| K024098 | ROCHE DIAGNOSTICS CORP. | COBAS INTEGRA CREATININE PLUS VER.2 ASSAY | 12/19/2002 |
| K003261 | ROCHE DIAGNOSTICS CORP. | CREATININE PLUS | 11/16/2000 |
| K073634 | SENTINEL CH. SpA | MULTIGENT CREATININE (ENZYMATIC) ASSAY | 06/19/2008 |
| K103376 | SEPPIM S.A.S. | ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL | 11/18/2011 |
| K212223 | Siemens Healthcare Diagnostics Inc. | Atellica CH Enzymatic Creatinine_3 (ECre3) | 11/24/2021 |
| K090330 | Siemens Healthcare Diagnostics Inc. | DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270 | 05/22/2009 |
| K070727 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS | ADVIA CHEMISTRY ENZYMATIC CREATININE_2 | 08/03/2007 |
| K050283 | STANBIO LABORATORY | CREATININE LIQUICOLOR | 06/30/2005 |
| K161527 | TECO DIAGNOSTICS, INC. | Teco Creatinine Enzymatic Reagent Kit | 07/21/2017 |
| K152835 | TECO DIAGNOSTICS, INC. | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | 03/07/2016 |
| K061412 | THERMO ELECTRON CORP. | THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 | 03/23/2007 |
| K070824 | THERMO FISHER SCIENTIFIC OY | CREATININE (ENZYMATIC) | 12/03/2007 |
| K061775 | WAKO CHEMICALS, USA, INC. | WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR | 02/23/2007 |
| K012065 | WIENER LABORATORIES S.A.I.C. | WIENER LAB. CREATININA CINETICA AA | 10/10/2001 |
| K182038 | YD Diagnostics Corporation | URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer | 12/10/2018 |
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