Panels › Clinical Chemistry › Product code CGX · Class 2
Alkaline Picrate, Colorimetry, Creatinine
Regulation 862.1225
2510(k)s in 12 months (159 all time)
1recalls in 12 months (15 all time)
15recalls that name a 510(k)
Top companies in CGX
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 9, 2026 | K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer Nova Biomedical Corporation | CGX |
| Nov 26, 2025 | K251058 | Tru Kidney Health Test Panel; Tru Analyzer Truvian Health | CGX |
| Dec 4, 2024 | K242685 | Atellica® CH Creatinine_3 (Crea3) Siemens Healthcare Diagnostics, Inc. | CGX |
| Nov 19, 2024 | K221813 | Nova Allegro UACR Assay, Nova Allegro Analyzer Nova Biomedical Corporation | CGX |
| Mar 22, 2022 | K210452 | Creatinine2 Abbott Ireland Diagnostics Division, IE | CGX |
| Nov 15, 2016 | K161494 | Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) Siemens Healthcare Diagnostics, Inc. | CGX |
| Jan 27, 2014 | K132638 | DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE Siemens Healthcare Diagnostics, Inc. | CGX |
| Jan 24, 2014 | K133728 | DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE Siemens Healthcare Diagnostics, Inc. | CGX |
| May 15, 2013 | K123586 | EASYRA CREATININE REAGENT Medica Corporation | CGX |
| Apr 30, 2012 | K110530 | ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL HORIBA ABX SAS, FR | CGX |
| Apr 7, 2009 | K083809 | CREATININE Abbott Laboratories | CGX |
| Nov 30, 2007 | K072115 | ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H Horiba Abx, FR | CGX |
| Jun 1, 2007 | K071283 | SYNCHRON SYSTEMS CREATININE REAGENT Beckman Coulter, Inc. | CGX |
| Jun 1, 2007 | K071280 | SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS Beckman Coulter, Inc. | CGX |
| Jun 1, 2007 | K071277 | SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS Beckman Coulter, Inc. | CGX |
| Jun 23, 2006 | K061193 | CREATININE Abbott Laboratories, Inc. | CGX |
| Apr 28, 2006 | K060935 | SYNCHRON SYSTEMS CREATININE (CREA) REAGENT Beckman Coulter, Inc. | CGX |
| Apr 6, 2005 | K050652 | SPOTCHEM II CREATININE, AMYLASE & ALP TESTS Arkray, Inc. | CGX |
| Dec 27, 2004 | K040976 | GENCHEM CREATININE REAGENT Genchem, Inc. | CGX |
| Jan 30, 2004 | K033058 | CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS Diamond Diagnostics, Inc. | CGX |
| Feb 14, 2003 | K023407 | ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR Elan Diagnostics | CGX |
| Dec 19, 2000 | K002156 | APPRAISE URINE MICROALBUMIN COLLECTION KIT Osborn Group, Inc. | CGX |
| Dec 14, 2000 | K003247 | CREATININE Jas Diagnostics, Inc. | CGX |
| Jun 21, 2000 | K001769 | VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT Ortho-Clinical Diagnostics | CGX |
| Feb 18, 2000 | K000055 | CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17 Diagnostic Chemicals , Ltd., CA | CGX |
| May 25, 1999 | K991109 | CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02 A.P. Total Care, Inc. | CGX |
| Jan 6, 1999 | K983937 | DUAL VIAL CREATININE REAGENT Intersect Systems, Inc. | CGX |
| Jul 22, 1998 | K981799 | CREA Abbott Laboratories | CGX |
| May 29, 1998 | K981240 | CREATININE (CREA) Abbott Laboratories | CGX |
| Mar 6, 1998 | K973993 | RANDOX CREATININE Randox Laboratories, Ltd., IE | CGX |
| Feb 24, 1998 | K974909 | SYNERMED CREATININE REAGENT KIT Synermed Intl., Inc., CA | CGX |
| Sep 22, 1997 | K972743 | SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT Sigma Diagnostics, Inc. | CGX |
| Jun 17, 1997 | K971908 | CREA OR CREATININE Carolina Liquid Chemistries Corp. | CGX |
| Mar 6, 1997 | K970087 | CR PERFECT Chimera Research & Chemical, Inc. | CGX |
| Sep 30, 1996 | K963534 | SIGMA DIAGNOSTICS CREATININE REAGENT KIT Sigma Diagnostics, Inc. | CGX |
| Mar 12, 1996 | K955938 | CREATININE REAGENT Derma Media Lab., Inc. | CGX |
| Oct 13, 1995 | K954266 | STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY Solarcare Technologies Corp,Inc. | CGX |
| Sep 8, 1995 | K951595 | ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES Roche Diagnostic Systems, Inc. | CGX |
| May 25, 1995 | K950142 | CR PERFECT Chimera Research & Chemical, Inc. | CGX |
| Jan 5, 1995 | K945655 | CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM) Miles, Inc. | CGX |
| Nov 22, 1994 | K943005 | CREATININE QVET Prisma Systems | CGX |
| Sep 20, 1994 | K943924 | CREATININE-PO REAGENT KIT Synermed, Inc., CA | CGX |
| Aug 26, 1994 | K941837 | ROCHE REAGENT FOR CREATININE Roche Diagnostic Systems, Inc. | CGX |
| Mar 21, 1994 | K934071 | KODAK EKTACHEM DT SLIDES (URCR) Eastman Kodak Company | CGX |
| Mar 11, 1994 | K934587 | CREATININE-S ASSAY Diagnostic Chemicals , Ltd., CA | CGX |
| Nov 16, 1993 | K934361 | OLYMPUS CREATININE REAGENT Olympus Corp. | CGX |
| Oct 18, 1993 | K933697 | SIGMA CRE REAGENT Sigma Chemical Co. | CGX |
| Sep 21, 1993 | K931939 | OLYMPUS CREATININE REAGENT Olympus Corp. | CGX |
| Jul 9, 1993 | K932160 | SYSTEMATE CREATININE TEST ITEM NUMBER 65413 Em Diagnostic Systems, Inc. | CGX |
| Feb 18, 1993 | K926511 | SYNERMED SINGLE REAGENT CREATININE KIT Synermed, Inc., CA | CGX |
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