FDA 510(k) Applications for Medical Device Product Code "CGX"
(Alkaline Picrate, Colorimetry, Creatinine)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K991109 | A.P. TOTAL CARE, INC. | CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02 | 05/25/1999 |
| K210452 | Abbott Ireland Diagnostics Division | Creatinine2 | 03/22/2022 |
| K981799 | ABBOTT LABORATORIES | CREA | 07/22/1998 |
| K083809 | ABBOTT LABORATORIES | CREATININE | 04/07/2009 |
| K981240 | ABBOTT LABORATORIES | CREATININE (CREA) | 05/29/1998 |
| K061193 | ABBOTT LABORATORIES INC | CREATININE | 06/23/2006 |
| K050652 | ARKRAY, INC. | SPOTCHEM II CREATININE, AMYLASE & ALP TESTS | 04/06/2005 |
| K071280 | BECKMAN COULTER, INC. | SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS | 06/01/2007 |
| K071277 | BECKMAN COULTER, INC. | SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS | 06/01/2007 |
| K060935 | BECKMAN COULTER, INC. | SYNCHRON SYSTEMS CREATININE (CREA) REAGENT | 04/28/2006 |
| K071283 | BECKMAN COULTER, INC. | SYNCHRON SYSTEMS CREATININE REAGENT | 06/01/2007 |
| K971908 | CAROLINA LIQUID CHEMISTRIES CORP. | CREA OR CREATININE | 06/17/1997 |
| K970087 | CHIMERA RESEARCH & CHEMICAL, INC. | CR PERFECT | 03/06/1997 |
| K955938 | DERMA MEDIA LAB., INC. | CREATININE REAGENT | 03/12/1996 |
| K000055 | DIAGNOSTIC CHEMICALS LTD. | CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17 | 02/18/2000 |
| K033058 | DIAMOND DIAGNOSTICS, INC. | CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS | 01/30/2004 |
| K023407 | ELAN DIAGNOSTICS | ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR | 02/14/2003 |
| K040976 | GENCHEM, INC. | GENCHEM CREATININE REAGENT | 12/27/2004 |
| K072115 | HORIBA ABX | ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H | 11/30/2007 |
| K110530 | HORIBA ABX S.A.S. | ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL | 04/30/2012 |
| K983937 | INTERSECT SYSTEMS, INC. | DUAL VIAL CREATININE REAGENT | 01/06/1999 |
| K003247 | JAS Diagnostics, Inc. | CREATININE | 12/14/2000 |
| K123586 | MEDICA CORPORATION | EASYRA CREATININE REAGENT | 05/15/2013 |
| K001769 | ORTHO-CLINICAL DIAGNOSTICS | VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT | 06/21/2000 |
| K002156 | OSBORN GROUP, INC. | APPRAISE URINE MICROALBUMIN COLLECTION KIT | 12/19/2000 |
| K973993 | RANDOX LABORATORIES, LTD. | RANDOX CREATININE | 03/06/1998 |
| K132638 | Siemens Healthcare Diagnostics Inc. | DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE | 01/27/2014 |
| K133728 | Siemens Healthcare Diagnostics Inc. | DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE | 01/24/2014 |
| K161494 | Siemens Healthcare Diagnostics, Inc. | Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) | 11/15/2016 |
| K963534 | SIGMA DIAGNOSTICS, INC. | SIGMA DIAGNOSTICS CREATININE REAGENT KIT | 09/30/1996 |
| K972743 | SIGMA DIAGNOSTICS, INC. | SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT | 09/22/1997 |
| K974909 | SYNERMED INTL., INC. | SYNERMED CREATININE REAGENT KIT | 02/24/1998 |
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