Panels › Clinical Chemistry › Product code JFY · Class 2
Enzymatic Method, Creatinine
Regulation 862.1225
1510(k)s in 12 months (49 all time)
0recalls in 12 months (29 all time)
29recalls that name a 510(k)
Top companies in JFY
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 20, 2026 | K252619 | QSCHECK UISACR Qstag, Inc., KR | JFY |
| Nov 24, 2021 | K212223 | Atellica CH Enzymatic Creatinine_3 (ECre3) Siemens Healthcare Diagnostics, Inc. | JFY |
| May 10, 2021 | K193649 | Yumizen C1200 Creatinine PAP HORIBA ABX SAS, FR | JFY |
| Jul 26, 2019 | K182384 | ACR LAB Urine Analysis Test System Healthy.Io, Ltd., IL | JFY |
| Feb 16, 2019 | K183555 | GEM Premier ChemSTAT Instrumentation Laboratory CO | JFY |
| Dec 10, 2018 | K182038 | URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer Yd Diagnostics Corporation, KR | JFY |
| Oct 30, 2018 | K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VIT Ortho-Clinical Diagnostics, Inc. | JFY |
| Jul 21, 2017 | K161527 | Teco Creatinine Enzymatic Reagent Kit Teco Diagnostics, Inc. | JFY |
| Mar 7, 2016 | K152835 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM Teco Diagnostics, Inc. | JFY |
| Dec 22, 2014 | K142391 | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) ACON Laboratories, Inc. | JFY |
| Jan 3, 2014 | K132399 | ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL Elitechgroup | JFY |
| Nov 18, 2011 | K103376 | ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL Seppim S.A.S. | JFY |
| Aug 10, 2011 | K110137 | ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN HORIBA ABX SAS, FR | JFY |
| Dec 4, 2009 | K093458 | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 Beckman Coulter, Inc. | JFY |
| Aug 14, 2009 | K091742 | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 Beckman Coulter, Inc. | JFY |
| May 22, 2009 | K090330 | DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270 Siemens Healthcare Diagnostics, Inc. | JFY |
| Jun 30, 2008 | K080073 | S-TEST CREATININE (CRE) Alfa Wassermann, Inc. | JFY |
| Jun 19, 2008 | K073634 | MULTIGENT CREATININE (ENZYMATIC) ASSAY SENTINEL CH. SpA, IT | JFY |
| Feb 12, 2008 | K072409 | AFINION ACR AND ACR CONTROL Axis-Shield Poc AS, NO | JFY |
| Jan 3, 2008 | K073055 | DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 Dade Behring, Inc. | JFY |
| Dec 3, 2007 | K070824 | CREATININE (ENZYMATIC) Thermofisher Scientific OY, FI | JFY |
| Aug 3, 2007 | K070727 | ADVIA CHEMISTRY ENZYMATIC CREATININE_2 Siemens Medical Solutions Diagnostics | JFY |
| Jun 22, 2007 | K070383 | ENZYMATIC CREATININE ASSAY (265 SERIES) Diagnostic Chemicals , Ltd., CA | JFY |
| May 25, 2007 | K071216 | VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927 Ortho-Clinical Diagnostics, Inc. | JFY |
| May 25, 2007 | K071215 | VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927 Ortho-Clinical Diagnostics, Inc. | JFY |
| Apr 23, 2007 | K062105 | DIAZYME CREATININE LIQUID REAGENTS ASSAY Diazyme Laboratories | JFY |
| Mar 23, 2007 | K061412 | THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 Thermo Electron Corp. | JFY |
| Feb 23, 2007 | K061775 | WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR Wako Chemicals USA, Inc. | JFY |
| Dec 15, 2006 | K063591 | VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208 Ortho-Clinical Diagnostics, Inc. | JFY |
| Nov 3, 2006 | K061944 | POLY-CHEM CREATININE Polymedco, Inc. | JFY |
| Jun 30, 2005 | K050283 | CREATININE LIQUICOLOR Stanbio Laboratory | JFY |
| Jun 25, 2003 | K030035 | IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE Diametrics Medical, Inc. | JFY |
| Dec 19, 2002 | K024098 | COBAS INTEGRA CREATININE PLUS VER.2 ASSAY Roche Diagnostics Corp. | JFY |
| Jul 5, 2002 | K021428 | CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM Bayer Corp. | JFY |
| Oct 10, 2001 | K012065 | WIENER LAB. CREATININA CINETICA AA Wiener Laboratories Saic, AR | JFY |
| Jun 20, 2001 | K010456 | BIOSCANNER CREATININE TEST STRIPS Polymer Technology Systems, Inc. | JFY |
| Nov 16, 2000 | K003261 | CREATININE PLUS Roche Diagnostics Corp. | JFY |
| May 5, 2000 | K001310 | VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 Ortho-Clinical Diagnostics, Inc. | JFY |
| Aug 10, 1999 | K984530 | DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE Metrika, Inc. | JFY |
| Mar 30, 1998 | K980043 | CARESIDE CREATININE Exigent Diagnostics, Inc. | JFY |
| Oct 31, 1991 | K912807 | ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17 Em Diagnostic Systems, Inc. | JFY |
| Aug 12, 1991 | K913105 | REFLOTRON CREATININE TEST TABS Boehringer Mannheim Corp. | JFY |
| Sep 7, 1990 | K903573 | REFLOTRON CREATININE TEST TABS Boehringer Mannheim Corp. | JFY |
| Feb 24, 1988 | K875191 | KODAK EKTACHEM DT SLIDES (CRSC) Eastman Kodak Company | JFY |
| Feb 12, 1987 | K864992 | RAICHEM(TM) CREATININE REAGENT (ENZYMATIC) Reagents Applications, Inc. | JFY |
| Sep 9, 1986 | K863078 | CREATININE-E J. D. Assoc. | JFY |
| Jan 17, 1986 | K854766 | CREATININE PAP Boehringer Mannheim Corp. | JFY |
| May 1, 1984 | K841070 | CREATININE REAGENT SET Medical Specialties, Inc. | JFY |
| Aug 31, 1981 | K812095 | ENXYMATIC CREATININE TEST Boehringer Mannheim Corp. | JFY |
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