Product code JFY— Clinical Chemistry
REFLOTRON CREATININE TEST TABS
- Classification name
- Enzymatic Method, Creatinine
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Total cleared
- 49
- First cleared
- Most recent
Market context for product code JFY
FDA has cleared devices under product code JFY between 1981 and 2026, filed by 37 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2021
- 2019
- 2018
- 2017
- 2016
- 2014
- 2011
- 2009
- 2008
- 2007
- 2006
- 2005
- 2003
- 2002
Top applicants under product code JFY
Recent clearances under product code JFY
- K252619 — QSCHECK UISACR
- K212223 — Atellica CH Enzymatic Creatinine_3 (ECre3)
- K193649 — Yumizen C1200 Creatinine PAP
- K182384 — ACR LAB Urine Analysis Test System
- K183555 — GEM Premier ChemSTAT
- K182038 — URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
- K182063 — VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System
- K161527 — Teco Creatinine Enzymatic Reagent Kit
- K152835 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
- K142391 — Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )
- K132399 — ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL
- K103376 — ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL
- K110137 — ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN
- K093458 — SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
- K091742 — SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
- K090330 — DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270
- K080073 — S-TEST CREATININE (CRE)
- K073634 — MULTIGENT CREATININE (ENZYMATIC) ASSAY
- K072409 — AFINION ACR AND ACR CONTROL
- K073055 — DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
- K070824 — CREATININE (ENZYMATIC)
- K070727 — ADVIA CHEMISTRY ENZYMATIC CREATININE_2
- K070383 — ENZYMATIC CREATININE ASSAY (265 SERIES)
- K071215 — VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927
- K071216 — VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927
- K062105 — DIAZYME CREATININE LIQUID REAGENTS ASSAY
- K061412 — THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401
- K061775 — WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
- K063591 — VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208
- K061944 — POLY-CHEM CREATININE
- K050283 — CREATININE LIQUICOLOR
- K030035 — IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE
- K024098 — COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
- K021428 — CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
- K012065 — WIENER LAB. CREATININA CINETICA AA
- K010456 — BIOSCANNER CREATININE TEST STRIPS
- K003261 — CREATININE PLUS
- K001310 — VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
- K984530 — DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE
- K980043 — CARESIDE CREATININE
- K912807 — ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17
- K913105 — REFLOTRON CREATININE TEST TABS
- K903573 — REFLOTRON CREATININE TEST TABS
- K875191 — KODAK EKTACHEM DT SLIDES (CRSC)
- K864992 — RAICHEM(TM) CREATININE REAGENT (ENZYMATIC)
- K863078 — CREATININE-E
- K854766 — CREATININE PAP
- K841070 — CREATININE REAGENT SET
- K812095 — ENXYMATIC CREATININE TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.