Atlas FDA

CGX

159 FDA 510(k) clearances · Product code

47 daysmedian time to decision
155 days90th percentile
159clearances measured

FDA profile

Official device name
Alkaline Picrate, Colorimetry, Creatinine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1225
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 13 · 2022: 23 · 2023: 19 · 2024: 32 · 2025: 36 · 2026: 33
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Nova Allegro UACR Assay, Nova Allegro Analyzer (K252206)Nova Biomedical Corporation2026-01-09
Tru Kidney Health Test Panel; Tru Analyzer (K251058)Truvian Health2025-11-26
Atellica® CH Creatinine_3 (Crea3) (K242685)Siemens Healthcare Diagnostics, Inc.2024-12-04
Nova Allegro UACR Assay, Nova Allegro Analyzer (K221813)Nova Biomedical Corporation2024-11-19
Creatinine2 (K210452)Abbott Ireland Diagnostics Division2022-03-22
Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) (K161494)Siemens Healthcare Diagnostics, Inc.2016-11-15
DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE (K132638)Siemens Healthcare Diagnostics, Inc.2014-01-27
DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE (K133728)Siemens Healthcare Diagnostics, Inc.2014-01-24
EASYRA CREATININE REAGENT (K123586)Medica Corporation2013-05-15
ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL (K110530)HORIBA ABX SAS2012-04-30
CREATININE (K083809)Abbott Laboratories2009-04-07
ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H (K072115)Horiba Abx2007-11-30
SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS (K071280)Beckman Coulter, Inc.2007-06-01
SYNCHRON SYSTEMS CREATININE REAGENT (K071283)Beckman Coulter, Inc.2007-06-01
SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS (K071277)Beckman Coulter, Inc.2007-06-01
CREATININE (K061193)Abbott Laboratories, Inc.2006-06-23
SYNCHRON SYSTEMS CREATININE (CREA) REAGENT (K060935)Beckman Coulter, Inc.2006-04-28
SPOTCHEM II CREATININE, AMYLASE & ALP TESTS (K050652)Arkray, Inc.2005-04-06
GENCHEM CREATININE REAGENT (K040976)Genchem, Inc.2004-12-27
CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS (K033058)Diamond Diagnostics, Inc.2004-01-30
ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR (K023407)Elan Diagnostics2003-02-14
APPRAISE URINE MICROALBUMIN COLLECTION KIT (K002156)Osborn Group, Inc.2000-12-19
CREATININE (K003247)Jas Diagnostics, Inc.2000-12-14
VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT (K001769)Ortho-Clinical Diagnostics2000-06-21
CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17 (K000055)Diagnostic Chemicals , Ltd.2000-02-18
CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02 (K991109)A.P. Total Care, Inc.1999-05-25
DUAL VIAL CREATININE REAGENT (K983937)Intersect Systems, Inc.1999-01-06
CREA (K981799)Abbott Laboratories1998-07-22
CREATININE (CREA) (K981240)Abbott Laboratories1998-05-29
RANDOX CREATININE (K973993)Randox Laboratories, Ltd.1998-03-06
SYNERMED CREATININE REAGENT KIT (K974909)Synermed Intl., Inc.1998-02-24
SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT (K972743)Sigma Diagnostics, Inc.1997-09-22
CREA OR CREATININE (K971908)Carolina Liquid Chemistries Corp.1997-06-17
CR PERFECT (K970087)Chimera Research & Chemical, Inc.1997-03-06
SIGMA DIAGNOSTICS CREATININE REAGENT KIT (K963534)Sigma Diagnostics, Inc.1996-09-30
CREATININE REAGENT (K955938)Derma Media Lab., Inc.1996-03-12
STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY (K954266)Solarcare Technologies Corp,Inc.1995-10-13
ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES (K951595)Roche Diagnostic Systems, Inc.1995-09-08
CR PERFECT (K950142)Chimera Research & Chemical, Inc.1995-05-25
CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM) (K945655)Miles, Inc.1995-01-05
CREATININE QVET (K943005)Prisma Systems1994-11-22
CREATININE-PO REAGENT KIT (K943924)Synermed, Inc.1994-09-20
ROCHE REAGENT FOR CREATININE (K941837)Roche Diagnostic Systems, Inc.1994-08-26
KODAK EKTACHEM DT SLIDES (URCR) (K934071)Eastman Kodak Company1994-03-21
CREATININE-S ASSAY (K934587)Diagnostic Chemicals , Ltd.1994-03-11
OLYMPUS CREATININE REAGENT (K934361)Olympus Corp.1993-11-16
SIGMA CRE REAGENT (K933697)Sigma Chemical Co.1993-10-18
OLYMPUS CREATININE REAGENT (K931939)Olympus Corp.1993-09-21
SYSTEMATE CREATININE TEST ITEM NUMBER 65413 (K932160)Em Diagnostic Systems, Inc.1993-07-09
SYNERMED SINGLE REAGENT CREATININE KIT (K926511)Synermed, Inc.1993-02-18
CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM (K925668)E.I. Dupont DE Nemours & Co., Inc.1992-12-28
OLYMPUS CREATININE REAGENT (K924692)Olympus Corp.1992-10-19
CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2 (K924599)Em Diagnostic Systems, Inc.1992-10-15
OLYMPUS CREATININE REAGENT (K923526)Olympus Corp.1992-09-18
SYSTEMATE CREATININE TEST (K923203)Em Diagnostic Systems, Inc.1992-09-09
MILES URINE CREATININE METHOD (K923039)Heraeus Kulzer, Inc.1992-08-24
SYNCHRON CREATININE TRIGGERED TEST CX4,5,7, (K915077)Beckman Instruments, Inc.1991-12-18
ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A28 (K913707)Em Diagnostic Systems, Inc.1991-09-18
SYSTEMATE CREATININE (EPOS APPLICATION) #65413 (K905658)Em Diagnostic Systems, Inc.1991-05-08
CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED (K910147)Olympus Corp.1991-03-11
CREATININE (RATE) REAGENT SET (K905619)Biochemical Trade, Inc.1991-02-13
N-A-G TEST KIT (K893582)Ppr Diagnostics , Ltd.1990-10-01
ROCHE COBAS READY CREATININE REAGENT (K902561)Roche Diagnostic Systems, Inc.1990-09-07
SYNERMED CREATININE REAGENT KIT (K903296)Synermed, Inc.1990-08-17
COULTER CREATININE REAGENT (K902172)Coulter Corp.1990-06-28
CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE) (K901229)Technicon Instruments Corp.1990-05-04
CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY (K901298)Olympus Corp.1990-04-25
AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791 (K900666)American Research Products Co.1990-04-19
AMRESCO CREATININE REAGENT #4316100 (K896686)American Research Products Co.1990-02-08
CREATININE 340 (ENZYMATIC) (K895847)Sclavo, Inc.1989-10-30
SYSTEMATE CREATININE TEST (CREA) #65413 (K895022)Em Diagnostic Systems, Inc.1989-10-23
HI CHEM CREATININE REAGENT (PRODUCT #88809) (K890671)Hichem Diagnostics1989-05-09
CREATININE TEST (CREA) ITEM #65663 (K884734)Em Diagnostic Systems, Inc.1988-12-19
BIOTROL CREATININE H.P. REAGENT (K881856)Biotrol, USA, Inc.1988-06-16
CREATININE FOR CONTINUOUS FLOW INSTRUMENTS (K881400)Catachem, Inc.1988-04-28
CREATININE REAGENT SET (KINETIC) (K880843)Tech-Neal Scientific, Inc.1988-04-05
CREATININE (K880629)Tech-Co, Inc.1988-03-23
PARAMAX CREATININE REAGENT (K873531)Baxter Healthcare Corp1987-11-23
EASY-TEST CREATININE (CREA) ITEM NO. 19009 (K874088)Em Diagnostic Systems, Inc.1987-11-06
CREATININE REAGENT KIT (K873131)A-Kem, Inc.1987-10-23
MULTICHEM CREATININE REAGENT S0917 (K873725)Simmler, Inc.1987-10-20
CREATININE REAGENT (K873365)Sigma Diagnostics, Inc.1987-10-02
ABBOTT SPECTRUM(R) LIQUID CREATININE REAGENT (K873310)Abbott Laboratories1987-09-02
CURAD MEDICATED PLASTIC STRIPS (K872310)The Kendal Co.1987-08-28
CREATININE REAGENT - PICRIC ACID METHOD (K870366)Trace Scientific , Ltd.1987-08-19
CREATINKINETIC (K863079)J. D. Assoc.1986-12-12
EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95 (K863738)Em Diagnostic Systems, Inc.1986-11-05
CREATININE PROCEDURE (K863261)Data Medical Associates, Inc.1986-10-02
CREATININE PROCEDURE (K861655)Data Medical Associates, Inc.1986-07-01
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CREA) (K861819)Eastman Kodak Company1986-06-11
CREATININE REAGENT SET (K860418)Sterling Diagnostics, Inc.1986-02-11
CREATININE REAGENT SET (K855193)Technostics Intl.1986-01-14
VISION CREATININE (K854846)Abbott Laboratories1986-01-13
IN-VITRO TEST FOR THE DETERMINATION OF CREATININE (K854178)Clinical Data, Inc.1985-11-25
AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 & (K853888)American Research Products Co.1985-10-15
TECHNICON CHEMI (K852565)Technicon Instruments Corp.1985-07-12
CREATININE (K850932)Dilab, Inc.1985-06-25
CRE BUFFER CRE DYE (K851993)Alpkem Corp.1985-05-30
CREATINE LIQUID STABLE REAGENT SET (K851849)Medical Analysis Systems, Inc.1985-05-20
CREATININE REAGENT FOR DEMAND ANALYZER (K844332)Advanced Biomedical Methods, Inc.1985-01-03
Next →

Track CGX automatically

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