Alkaline Picrate, Colorimetry, Creatinine

FDA product code CGX · 157 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1225
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-02-11 – 2026-01-09

CGX 2026-01-09

Nova Allegro UACR Assay, Nova Allegro Analyzer

Applicant Nova Biomedical Corporation

K number K252206

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CGX 2025-11-26

Tru Kidney Health Test Panel; Tru Analyzer

Applicant Truvian Health

K number K251058

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CGX 2024-12-04

Atellica® CH Creatinine_3 (Crea3)

Applicant Siemens Healthcare Diagnostics, Inc.

K number K242685

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CGX 2024-11-19

Nova Allegro UACR Assay, Nova Allegro Analyzer

Applicant Nova Biomedical Corporation

K number K221813

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CGX 2022-03-22

Creatinine2

Applicant Abbott Ireland Diagnostics Division

K number K210452

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CGX 2016-11-15

Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)

Applicant Siemens Healthcare Diagnostics, Inc.

K number K161494

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CGX 2013-05-15

EASYRA CREATININE REAGENT

Applicant Medica Corporation

K number K123586

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CGX 2012-04-30

ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL

Applicant HORIBA ABX SAS

K number K110530

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CGX 2009-04-07

CREATININE

Applicant Abbott Laboratories

K number K083809

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CGX 2007-11-30

ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H

Applicant Horiba Abx

K number K072115

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CGX 2007-06-01

SYNCHRON SYSTEMS CREATININE REAGENT

Applicant Beckman Coulter, Inc.

K number K071283

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CGX 2007-06-01

SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS

Applicant Beckman Coulter, Inc.

K number K071280

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CGX 2007-06-01

SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS

Applicant Beckman Coulter, Inc.

K number K071277

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CGX 2006-06-23

CREATININE

Applicant Abbott Laboratories, Inc.

K number K061193

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CGX 2006-04-28

SYNCHRON SYSTEMS CREATININE (CREA) REAGENT

Applicant Beckman Coulter, Inc.

K number K060935

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CGX 2005-04-06

SPOTCHEM II CREATININE, AMYLASE & ALP TESTS

Applicant Arkray, Inc.

K number K050652

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CGX 2004-12-27

GENCHEM CREATININE REAGENT

Applicant Genchem, Inc.

K number K040976

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CGX 2004-01-30

CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS

Applicant Diamond Diagnostics, Inc.

K number K033058

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CGX 2003-02-14

ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR

Applicant Elan Diagnostics

K number K023407

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CGX 2000-12-19

APPRAISE URINE MICROALBUMIN COLLECTION KIT

Applicant Osborn Group, Inc.

K number K002156

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CGX 2000-12-14

CREATININE

Applicant Jas Diagnostics, Inc.

K number K003247

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CGX 2000-06-21

VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT

Applicant Ortho-Clinical Diagnostics

K number K001769

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CGX 2000-02-18

CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17

Applicant Diagnostic Chemicals , Ltd.

K number K000055

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CGX 1999-05-25

CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02

Applicant A.P. Total Care, Inc.

K number K991109

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CGX 1999-01-06

DUAL VIAL CREATININE REAGENT

Applicant Intersect Systems, Inc.

K number K983937

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CGX 1998-07-22

CREA

Applicant Abbott Laboratories

K number K981799

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CGX 1998-05-29

CREATININE (CREA)

Applicant Abbott Laboratories

K number K981240

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CGX 1998-03-06

RANDOX CREATININE

Applicant Randox Laboratories, Ltd.

K number K973993

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CGX 1998-02-24

SYNERMED CREATININE REAGENT KIT

Applicant Synermed Intl., Inc.

K number K974909

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CGX 1997-09-22

SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT

Applicant Sigma Diagnostics, Inc.

K number K972743

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CGX 1997-06-17

CREA OR CREATININE

Applicant Carolina Liquid Chemistries Corp.

K number K971908

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CGX 1997-03-06

CR PERFECT

Applicant Chimera Research & Chemical, Inc.

K number K970087

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CGX 1996-09-30

SIGMA DIAGNOSTICS CREATININE REAGENT KIT

Applicant Sigma Diagnostics, Inc.

K number K963534

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CGX 1996-03-12

CREATININE REAGENT

Applicant Derma Media Lab., Inc.

K number K955938

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CGX 1995-10-13

STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY

Applicant Solarcare Technologies Corp,Inc.

K number K954266

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CGX 1995-09-08

ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES

Applicant Roche Diagnostic Systems, Inc.

K number K951595

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CGX 1995-05-25

CR PERFECT

Applicant Chimera Research & Chemical, Inc.

K number K950142

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CGX 1995-01-05

CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM)

Applicant Miles, Inc.

K number K945655

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CGX 1994-11-22

CREATININE QVET

Applicant Prisma Systems

K number K943005

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CGX 1994-09-20

CREATININE-PO REAGENT KIT

Applicant Synermed, Inc.

K number K943924

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CGX 1994-08-26

ROCHE REAGENT FOR CREATININE

Applicant Roche Diagnostic Systems, Inc.

K number K941837

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CGX 1994-03-21

KODAK EKTACHEM DT SLIDES (URCR)

Applicant Eastman Kodak Company

K number K934071

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CGX 1994-03-11

CREATININE-S ASSAY

Applicant Diagnostic Chemicals , Ltd.

K number K934587

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CGX 1993-11-16

OLYMPUS CREATININE REAGENT

Applicant Olympus Corp.

K number K934361

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CGX 1993-10-18

SIGMA CRE REAGENT

Applicant Sigma Chemical Co.

K number K933697

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CGX 1993-09-21

OLYMPUS CREATININE REAGENT

Applicant Olympus Corp.

K number K931939

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CGX 1993-07-09

SYSTEMATE CREATININE TEST ITEM NUMBER 65413

Applicant Em Diagnostic Systems, Inc.

K number K932160

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CGX 1993-02-18

SYNERMED SINGLE REAGENT CREATININE KIT

Applicant Synermed, Inc.

K number K926511

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CGX 1992-12-28

CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K925668

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CGX 1992-10-19

OLYMPUS CREATININE REAGENT

Applicant Olympus Corp.

K number K924692

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CGX 1992-10-15

CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2

Applicant Em Diagnostic Systems, Inc.

K number K924599

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CGX 1992-09-18

OLYMPUS CREATININE REAGENT

Applicant Olympus Corp.

K number K923526

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CGX 1992-09-09

SYSTEMATE CREATININE TEST

Applicant Em Diagnostic Systems, Inc.

K number K923203

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CGX 1992-08-24

MILES URINE CREATININE METHOD

Applicant Heraeus Kulzer, Inc.

K number K923039

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CGX 1991-12-18

SYNCHRON CREATININE TRIGGERED TEST CX4,5,7,

Applicant Beckman Instruments, Inc.

K number K915077

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CGX 1991-09-18

ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A28

Applicant Em Diagnostic Systems, Inc.

K number K913707

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CGX 1991-05-08

SYSTEMATE CREATININE (EPOS APPLICATION) #65413

Applicant Em Diagnostic Systems, Inc.

K number K905658

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CGX 1991-03-11

CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED

Applicant Olympus Corp.

K number K910147

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CGX 1991-02-13

CREATININE (RATE) REAGENT SET

Applicant Biochemical Trade, Inc.

K number K905619

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CGX 1990-10-01

N-A-G TEST KIT

Applicant Ppr Diagnostics , Ltd.

K number K893582

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CGX 1990-09-07

ROCHE COBAS READY CREATININE REAGENT

Applicant Roche Diagnostic Systems, Inc.

K number K902561

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CGX 1990-08-17

SYNERMED CREATININE REAGENT KIT

Applicant Synermed, Inc.

K number K903296

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CGX 1990-06-28

COULTER CREATININE REAGENT

Applicant Coulter Corp.

K number K902172

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CGX 1990-05-04

CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE)

Applicant Technicon Instruments Corp.

K number K901229

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CGX 1990-04-25

CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY

Applicant Olympus Corp.

K number K901298

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CGX 1990-04-19

AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791

Applicant American Research Products Co.

K number K900666

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CGX 1990-02-08

AMRESCO CREATININE REAGENT #4316100

Applicant American Research Products Co.

K number K896686

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CGX 1989-10-30

CREATININE 340 (ENZYMATIC)

Applicant Sclavo, Inc.

K number K895847

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CGX 1989-10-23

SYSTEMATE CREATININE TEST (CREA) #65413

Applicant Em Diagnostic Systems, Inc.

K number K895022

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CGX 1989-05-09

HI CHEM CREATININE REAGENT (PRODUCT #88809)

Applicant Hichem Diagnostics

K number K890671

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CGX 1988-12-19

CREATININE TEST (CREA) ITEM #65663

Applicant Em Diagnostic Systems, Inc.

K number K884734

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CGX 1988-06-16

BIOTROL CREATININE H.P. REAGENT

Applicant Biotrol, USA, Inc.

K number K881856

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CGX 1988-04-28

CREATININE FOR CONTINUOUS FLOW INSTRUMENTS

Applicant Catachem, Inc.

K number K881400

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CGX 1988-04-05

CREATININE REAGENT SET (KINETIC)

Applicant Tech-Neal Scientific, Inc.

K number K880843

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CGX 1988-03-23

CREATININE

Applicant Tech-Co, Inc.

K number K880629

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CGX 1987-11-23

PARAMAX CREATININE REAGENT

Applicant Baxter Healthcare Corp

K number K873531

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CGX 1987-11-06

EASY-TEST CREATININE (CREA) ITEM NO. 19009

Applicant Em Diagnostic Systems, Inc.

K number K874088

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CGX 1987-10-23

CREATININE REAGENT KIT

Applicant A-Kem, Inc.

K number K873131

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CGX 1987-10-20

MULTICHEM CREATININE REAGENT S0917

Applicant Simmler, Inc.

K number K873725

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CGX 1987-10-02

CREATININE REAGENT

Applicant Sigma Diagnostics, Inc.

K number K873365

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CGX 1987-09-02

ABBOTT SPECTRUM(R) LIQUID CREATININE REAGENT

Applicant Abbott Laboratories

K number K873310

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CGX 1987-08-28

CURAD MEDICATED PLASTIC STRIPS

Applicant The Kendal Co.

K number K872310

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CGX 1987-08-19

CREATININE REAGENT - PICRIC ACID METHOD

Applicant Trace Scientific , Ltd.

K number K870366

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CGX 1986-12-12

CREATINKINETIC

Applicant J. D. Assoc.

K number K863079

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CGX 1986-11-05

EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95

Applicant Em Diagnostic Systems, Inc.

K number K863738

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CGX 1986-10-02

CREATININE PROCEDURE

Applicant Data Medical Associates, Inc.

K number K863261

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CGX 1986-07-01

CREATININE PROCEDURE

Applicant Data Medical Associates, Inc.

K number K861655

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CGX 1986-06-11

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CREA)

Applicant Eastman Kodak Company

K number K861819

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CGX 1986-02-11

CREATININE REAGENT SET

Applicant Sterling Diagnostics, Inc.

K number K860418

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CGX 1986-01-14

CREATININE REAGENT SET

Applicant Technostics Intl.

K number K855193

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CGX 1986-01-13

VISION CREATININE

Applicant Abbott Laboratories

K number K854846

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CGX 1985-11-25

IN-VITRO TEST FOR THE DETERMINATION OF CREATININE

Applicant Clinical Data, Inc.

K number K854178

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CGX 1985-10-15

AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 &

Applicant American Research Products Co.

K number K853888

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CGX 1985-07-12

TECHNICON CHEMI

Applicant Technicon Instruments Corp.

K number K852565

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CGX 1985-06-25

CREATININE

Applicant Dilab, Inc.

K number K850932

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CGX 1985-05-30

CRE BUFFER CRE DYE

Applicant Alpkem Corp.

K number K851993

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CGX 1985-05-20

CREATINE LIQUID STABLE REAGENT SET

Applicant Medical Analysis Systems, Inc.

K number K851849

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CGX 1985-01-03

CREATININE REAGENT FOR DEMAND ANALYZER

Applicant Advanced Biomedical Methods, Inc.

K number K844332

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CGX 1984-10-30

CREATININE REAGENT SET

Applicant Livonia Diagnostics, Inc.

K number K844024

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CGX 1984-10-30

TDX REA CREATININE

Applicant Abbott Laboratories

K number K843916

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