FDA Product Code
FDA Product Code JFY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1225
510(k) Clearances — 49 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252619 | QSCHECK UISACR | Qstag, Inc. | 2026-02-20 | Traditional | PDF ↗ |
| K212223 | Atellica CH Enzymatic Creatinine_3 (ECre3) | Siemens Healthcare Diagnostics, Inc. | 2021-11-24 | Traditional | PDF ↗ |
| K193649 | Yumizen C1200 Creatinine PAP | HORIBA ABX SAS | 2021-05-10 | Traditional | PDF ↗ |
| K182384 | ACR LAB Urine Analysis Test System | Healthy.Io, Ltd. | 2019-07-26 | Traditional | PDF ↗ |
| K183555 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2019-02-16 | Traditional | PDF ↗ |
| K182038 | URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer | Yd Diagnostics Corporation | 2018-12-10 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K161527 | Teco Creatinine Enzymatic Reagent Kit | Teco Diagnostics, Inc. | 2017-07-21 | Traditional | PDF ↗ |
| K152835 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | Teco Diagnostics, Inc. | 2016-03-07 | Traditional | PDF ↗ |
| K142391 | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) | ACON Laboratories, Inc. | 2014-12-22 | Traditional | PDF ↗ |
| K132399 | ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL | Elitechgroup | 2014-01-03 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| 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 | Abbreviated | PDF ↗ |
| K093458 | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 | Beckman Coulter, Inc. | 2009-12-04 | Special | PDF ↗ |
| K091742 | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 | Beckman Coulter, Inc. | 2009-08-14 | Traditional | PDF ↗ |
| K090330 | DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270 | Siemens Healthcare Diagnostics, Inc. | 2009-05-22 | Traditional | PDF ↗ |
| K080073 | S-TEST CREATININE (CRE) | Alfa Wassermann, Inc. | 2008-06-30 | Traditional | PDF ↗ |
| K073634 | MULTIGENT CREATININE (ENZYMATIC) ASSAY | SENTINEL CH. SpA | 2008-06-19 | Traditional | PDF ↗ |
| K072409 | AFINION ACR AND ACR CONTROL | Axis-Shield Poc AS | 2008-02-12 | Traditional | PDF ↗ |
| K073055 | DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 | Dade Behring, Inc. | 2008-01-03 | Traditional | PDF ↗ |
| K070824 | CREATININE (ENZYMATIC) | Thermofisher Scientific OY | 2007-12-03 | Traditional | PDF ↗ |
| K070727 | ADVIA CHEMISTRY ENZYMATIC CREATININE_2 | Siemens Medical Solutions Diagnostics | 2007-08-03 | Traditional | PDF ↗ |
| K070383 | ENZYMATIC CREATININE ASSAY (265 SERIES) | Diagnostic Chemicals , Ltd. | 2007-06-22 | Traditional | PDF ↗ |
| K071216 | VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927 | Ortho-Clinical Diagnostics, Inc. | 2007-05-25 | Special | PDF ↗ |
| K071215 | VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927 | Ortho-Clinical Diagnostics, Inc. | 2007-05-25 | Special | PDF ↗ |
| K062105 | DIAZYME CREATININE LIQUID REAGENTS ASSAY | Diazyme Laboratories | 2007-04-23 | Traditional | PDF ↗ |
| K061412 | THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 | Thermo Electron Corp. | 2007-03-23 | Traditional | PDF ↗ |
| K061775 | WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR | Wako Chemicals USA, Inc. | 2007-02-23 | Traditional | PDF ↗ |
| K063591 | VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208 | Ortho-Clinical Diagnostics, Inc. | 2006-12-15 | Special | PDF ↗ |
| K061944 | POLY-CHEM CREATININE | Polymedco, Inc. | 2006-11-03 | Traditional | PDF ↗ |
| K050283 | CREATININE LIQUICOLOR | Stanbio Laboratory | 2005-06-30 | Traditional | PDF ↗ |
| K030035 | IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE | Diametrics Medical, Inc. | 2003-06-25 | Traditional | PDF ↗ |
| K024098 | COBAS INTEGRA CREATININE PLUS VER.2 ASSAY | Roche Diagnostics Corp. | 2002-12-19 | Special | PDF ↗ |
| K021428 | CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM | Bayer Corp. | 2002-07-05 | Traditional | PDF ↗ |
| K012065 | WIENER LAB. CREATININA CINETICA AA | Wiener Laboratories Saic | 2001-10-10 | Traditional | PDF ↗ |
| K010456 | BIOSCANNER CREATININE TEST STRIPS | Polymer Technology Systems, Inc. | 2001-06-20 | Traditional | PDF ↗ |
| K003261 | CREATININE PLUS | Roche Diagnostics Corp. | 2000-11-16 | Special | PDF ↗ |
| K001310 | VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 | Ortho-Clinical Diagnostics, Inc. | 2000-05-05 | Special | PDF ↗ |
| K984530 | DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE | Metrika, Inc. | 1999-08-10 | Traditional | PDF ↗ |
| K980043 | CARESIDE CREATININE | Exigent Diagnostics, Inc. | 1998-03-30 | Traditional | PDF ↗ |
| K912807 | ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17 | Em Diagnostic Systems, Inc. | 1991-10-31 | Traditional | PDF ↗ |
| K913105 | REFLOTRON CREATININE TEST TABS | Boehringer Mannheim Corp. | 1991-08-12 | Traditional | PDF ↗ |
| K903573 | REFLOTRON CREATININE TEST TABS | Boehringer Mannheim Corp. | 1990-09-07 | Traditional | PDF ↗ |
| K875191 | KODAK EKTACHEM DT SLIDES (CRSC) | Eastman Kodak Company | 1988-02-24 | Traditional | PDF ↗ |
| K864992 | RAICHEM(TM) CREATININE REAGENT (ENZYMATIC) | Reagents Applications, Inc. | 1987-02-12 | Traditional | PDF ↗ |
| K863078 | CREATININE-E | J. D. Assoc. | 1986-09-09 | Traditional | PDF ↗ |
| K854766 | CREATININE PAP | Boehringer Mannheim Corp. | 1986-01-17 | Traditional | PDF ↗ |
| K841070 | CREATININE REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K812095 | ENXYMATIC CREATININE TEST | Boehringer Mannheim Corp. | 1981-08-31 | Traditional | PDF ↗ |
Product code JFY · Class II · Clinical Chemistry. Data: openFDA.