Atlas FDA

JFY

49 FDA 510(k) clearances · Product code

117 daysmedian time to decision
305 days90th percentile
49clearances measured

FDA profile

Official device name
Enzymatic Method, Creatinine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1225
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
2020: 34 · 2021: 57 · 2023: 36 · 2024: 34 · 2025: 60 · 2026: 37
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
QSCHECK UISACR (K252619)Qstag, Inc.2026-02-20
Atellica CH Enzymatic Creatinine_3 (ECre3) (K212223)Siemens Healthcare Diagnostics, Inc.2021-11-24
Yumizen C1200 Creatinine PAP (K193649)HORIBA ABX SAS2021-05-10
ACR LAB Urine Analysis Test System (K182384)Healthy.Io, Ltd.2019-07-26
GEM Premier ChemSTAT (K183555)Instrumentation Laboratory CO2019-02-16
URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer (K182038)Yd Diagnostics Corporation2018-12-10
VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System (K182063)Ortho-Clinical Diagnostics, Inc.2018-10-30
Teco Creatinine Enzymatic Reagent Kit (K161527)Teco Diagnostics, Inc.2017-07-21
URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (K152835)Teco Diagnostics, Inc.2016-03-07
Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) (K142391)ACON Laboratories, Inc.2014-12-22
ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL (K132399)Elitechgroup2014-01-03
ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL (K103376)Seppim S.A.S.2011-11-18
ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN (K110137)HORIBA ABX SAS2011-08-10
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 (K093458)Beckman Coulter, Inc.2009-12-04
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 (K091742)Beckman Coulter, Inc.2009-08-14
DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270 (K090330)Siemens Healthcare Diagnostics, Inc.2009-05-22
S-TEST CREATININE (CRE) (K080073)Alfa Wassermann, Inc.2008-06-30
MULTIGENT CREATININE (ENZYMATIC) ASSAY (K073634)SENTINEL CH. SpA2008-06-19
AFINION ACR AND ACR CONTROL (K072409)Axis-Shield Poc AS2008-02-12
DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 (K073055)Dade Behring, Inc.2008-01-03
CREATININE (ENZYMATIC) (K070824)Thermofisher Scientific OY2007-12-03
ADVIA CHEMISTRY ENZYMATIC CREATININE_2 (K070727)Siemens Medical Solutions Diagnostics2007-08-03
ENZYMATIC CREATININE ASSAY (265 SERIES) (K070383)Diagnostic Chemicals , Ltd.2007-06-22
VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927 (K071216)Ortho-Clinical Diagnostics, Inc.2007-05-25
VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927 (K071215)Ortho-Clinical Diagnostics, Inc.2007-05-25
DIAZYME CREATININE LIQUID REAGENTS ASSAY (K062105)Diazyme Laboratories2007-04-23
THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 (K061412)Thermo Electron Corp.2007-03-23
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR (K061775)Wako Chemicals USA, Inc.2007-02-23
VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208 (K063591)Ortho-Clinical Diagnostics, Inc.2006-12-15
POLY-CHEM CREATININE (K061944)Polymedco, Inc.2006-11-03
CREATININE LIQUICOLOR (K050283)Stanbio Laboratory2005-06-30
IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE (K030035)Diametrics Medical, Inc.2003-06-25
COBAS INTEGRA CREATININE PLUS VER.2 ASSAY (K024098)Roche Diagnostics Corp.2002-12-19
CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM (K021428)Bayer Corp.2002-07-05
WIENER LAB. CREATININA CINETICA AA (K012065)Wiener Laboratories Saic2001-10-10
BIOSCANNER CREATININE TEST STRIPS (K010456)Polymer Technology Systems, Inc.2001-06-20
CREATININE PLUS (K003261)Roche Diagnostics Corp.2000-11-16
VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 (K001310)Ortho-Clinical Diagnostics, Inc.2000-05-05
DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE (K984530)Metrika, Inc.1999-08-10
CARESIDE CREATININE (K980043)Exigent Diagnostics, Inc.1998-03-30
ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17 (K912807)Em Diagnostic Systems, Inc.1991-10-31
REFLOTRON CREATININE TEST TABS (K913105)Boehringer Mannheim Corp.1991-08-12
REFLOTRON CREATININE TEST TABS (K903573)Boehringer Mannheim Corp.1990-09-07
KODAK EKTACHEM DT SLIDES (CRSC) (K875191)Eastman Kodak Company1988-02-24
RAICHEM(TM) CREATININE REAGENT (ENZYMATIC) (K864992)Reagents Applications, Inc.1987-02-12
CREATININE-E (K863078)J. D. Assoc.1986-09-09
CREATININE PAP (K854766)Boehringer Mannheim Corp.1986-01-17
CREATININE REAGENT SET (K841070)Medical Specialties, Inc.1984-05-01
ENXYMATIC CREATININE TEST (K812095)Boehringer Mannheim Corp.1981-08-31

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Every clearance here is in the API, with alerts when new ones post.