Product code CGX— Clinical Chemistry
CREATININE
- Classification name
- Alkaline Picrate, Colorimetry, Creatinine
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Total cleared
- 159
- First cleared
- Most recent
Market context for product code CGX
FDA has cleared devices under product code CGX between 1977 and 2026, filed by 96 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
- 2025
- 2024
- 2022
- 2016
- 2014
- 2013
- 2012
- 2009
- 2007
- 2006
- 2005
- 2004
- 2003
- 2000
Top applicants under product code CGX
Recent clearances under product code CGX
1–100 of 159- K252206 — Nova Allegro UACR Assay, Nova Allegro Analyzer
- K251058 — Tru Kidney Health Test Panel; Tru Analyzer
- K242685 — Atellica® CH Creatinine_3 (Crea3)
- K221813 — Nova Allegro UACR Assay, Nova Allegro Analyzer
- K210452 — Creatinine2
- K161494 — Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)
- K132638 — DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE
- K133728 — DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE
- K123586 — EASYRA CREATININE REAGENT
- K110530 — ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL
- K083809 — CREATININE
- K072115 — ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H
- K071277 — SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
- K071280 — SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
- K071283 — SYNCHRON SYSTEMS CREATININE REAGENT
- K061193 — CREATININE
- K060935 — SYNCHRON SYSTEMS CREATININE (CREA) REAGENT
- K050652 — SPOTCHEM II CREATININE, AMYLASE & ALP TESTS
- K040976 — GENCHEM CREATININE REAGENT
- K033058 — CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
- K023407 — ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR
- K002156 — APPRAISE URINE MICROALBUMIN COLLECTION KIT
- K003247 — CREATININE
- K001769 — VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT
- K000055 — CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17
- K991109 — CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02
- K983937 — DUAL VIAL CREATININE REAGENT
- K981799 — CREA
- K981240 — CREATININE (CREA)
- K973993 — RANDOX CREATININE
- K974909 — SYNERMED CREATININE REAGENT KIT
- K972743 — SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT
- K971908 — CREA OR CREATININE
- K970087 — CR PERFECT
- K963534 — SIGMA DIAGNOSTICS CREATININE REAGENT KIT
- K955938 — CREATININE REAGENT
- K954266 — STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY
- K951595 — ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES
- K950142 — CR PERFECT
- K945655 — CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM)
- K943005 — CREATININE QVET
- K943924 — CREATININE-PO REAGENT KIT
- K941837 — ROCHE REAGENT FOR CREATININE
- K934071 — KODAK EKTACHEM DT SLIDES (URCR)
- K934587 — CREATININE-S ASSAY
- K934361 — OLYMPUS CREATININE REAGENT
- K933697 — SIGMA CRE REAGENT
- K931939 — OLYMPUS CREATININE REAGENT
- K932160 — SYSTEMATE CREATININE TEST ITEM NUMBER 65413
- K926511 — SYNERMED SINGLE REAGENT CREATININE KIT
- K925668 — CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM
- K924692 — OLYMPUS CREATININE REAGENT
- K924599 — CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2
- K923526 — OLYMPUS CREATININE REAGENT
- K923203 — SYSTEMATE CREATININE TEST
- K923039 — MILES URINE CREATININE METHOD
- K915077 — SYNCHRON CREATININE TRIGGERED TEST CX4,5,7,
- K913707 — ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A28
- K905658 — SYSTEMATE CREATININE (EPOS APPLICATION) #65413
- K910147 — CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED
- K905619 — CREATININE (RATE) REAGENT SET
- K893582 — N-A-G TEST KIT
- K902561 — ROCHE COBAS READY CREATININE REAGENT
- K903296 — SYNERMED CREATININE REAGENT KIT
- K902172 — COULTER CREATININE REAGENT
- K901229 — CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE)
- K901298 — CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY
- K900666 — AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791
- K896686 — AMRESCO CREATININE REAGENT #4316100
- K895847 — CREATININE 340 (ENZYMATIC)
- K895022 — SYSTEMATE CREATININE TEST (CREA) #65413
- K890671 — HI CHEM CREATININE REAGENT (PRODUCT #88809)
- K884734 — CREATININE TEST (CREA) ITEM #65663
- K881856 — BIOTROL CREATININE H.P. REAGENT
- K881400 — CREATININE FOR CONTINUOUS FLOW INSTRUMENTS
- K880843 — CREATININE REAGENT SET (KINETIC)
- K880629 — CREATININE
- K873531 — PARAMAX CREATININE REAGENT
- K874088 — EASY-TEST CREATININE (CREA) ITEM NO. 19009
- K873131 — CREATININE REAGENT KIT
- K873725 — MULTICHEM CREATININE REAGENT S0917
- K873365 — CREATININE REAGENT
- K873310 — ABBOTT SPECTRUM(R) LIQUID CREATININE REAGENT
- K872310 — CURAD MEDICATED PLASTIC STRIPS
- K870366 — CREATININE REAGENT - PICRIC ACID METHOD
- K863079 — CREATINKINETIC
- K863738 — EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95
- K863261 — CREATININE PROCEDURE
- K861655 — CREATININE PROCEDURE
- K861819 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CREA)
- K860418 — CREATININE REAGENT SET
- K855193 — CREATININE REAGENT SET
- K854846 — VISION CREATININE
- K854178 — IN-VITRO TEST FOR THE DETERMINATION OF CREATININE
- K853888 — AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 &
- K852565 — TECHNICON CHEMI
- K850932 — CREATININE
- K851993 — CRE BUFFER CRE DYE
- K851849 — CREATINE LIQUID STABLE REAGENT SET
- K844332 — CREATININE REAGENT FOR DEMAND ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.