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 1984-09-28

CREATININE ASSAY KIT

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K843377

View details →

CGX 1984-09-07

CREATININE TEST

Applicant Sclavo, Inc.

K number K843179

View details →

CGX 1984-08-27

SYSTEMATE CREATININE 67223

Applicant Em Diagnostic Systems, Inc.

K number K843105

View details →

CGX 1984-08-16

CREATININE ASSAY KIT-KINETIC OR ENDPOINT

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K842159

View details →

CGX 1984-05-11

CREATININE - A.A.S.

Applicant Advanced Analytical Systems, Inc.

K number K841377

View details →

CGX 1984-04-18

RAICHEM CREATININE REAGENT

Applicant Reagents Applications, Inc.

K number K840872

View details →

CGX 1984-01-17

CREATININE REAGENT SET

Applicant Amresco, Inc.

K number K832439

View details →

CGX 1983-07-06

CREATININE REAGENTS B6370-13

Applicant American Scientific Products

K number K831628

View details →

CGX 1983-07-06

CREATININE REAGENTS B6360-10

Applicant American Scientific Products

K number K831627

View details →

CGX 1983-03-24

CREATININE

Applicant Pointe Scientific, Inc.,

K number K830556

View details →

CGX 1983-03-24

FLOW-PAC CREATININE REAGENT SET

Applicant Amresco, Inc.

K number K830537

View details →

CGX 1983-03-24

KINETIC CREATININE

Applicant American Monitor Corp.

K number K830447

View details →

CGX 1983-01-14

DIRECT CREATININE PROCEDURE

Applicant Analytical & Research Chemicals, Inc.

K number K823806

View details →

CGX 1983-01-07

COBAS REAGENT FOR CREATININE

Applicant Hoffmann-La Roche, Inc.

K number K823573

View details →

CGX 1983-01-07

COBAS STANDARDS FOR CREATININE

Applicant Hoffmann-La Roche, Inc.

K number K823572

View details →

CGX 1982-09-30

FERMCOTEST CREATININE TEST REAGENT

Applicant Fermco Biochemics, Inc.

K number K822118

View details →

CGX 1982-07-14

ULTRACHEM CREA

Applicant Harleco Diagnostics

K number K821881

View details →

CGX 1982-07-13

CREATININE REAGENT SET

Applicant Omega Medical Electronics

K number K821199

View details →

CGX 1982-01-29

LIQUIZYME CREATININE REAGENT SET

Applicant Amresco, Inc.

K number K813560

View details →

CGX 1982-01-26

SERALYZER CREATININE REAGENT STRIPS

Applicant Miles Laboratories, Inc.

K number K820075

View details →

CGX 1981-12-03

CREATININE REAGENT SET

Applicant Anco Medical Reagents & Assoc.

K number K812834

View details →

CGX 1981-11-10

ULTRACHEM CREA ITEM #64972

Applicant Harleco

K number K813043

View details →

CGX 1981-08-13

GILCHEM CREATININE REAGENT

Applicant Gilford Diagnostics

K number K812109

View details →

CGX 1981-08-13

CREATININE RATE REAGENT KIT

Applicant Chem-Elec, Inc.

K number K811406

View details →

CGX 1981-06-26

CREATININE REAGENT

Applicant Gilford Diagnostics

K number K811659

View details →

CGX 1981-06-25

CREATININE TEST

Applicant King Diagnostics, Inc.

K number K811664

View details →

CGX 1981-01-02

LANCER CREATININE MICROSAMPLE STAT ANA

Applicant Sherwood Medical Co.

K number K803087

View details →

CGX 1980-10-10

REAGENTS SERUM CREATINE USING TECHICON

Applicant Panmed, Inc.

K number K802156

View details →

CGX 1980-05-28

REAGENT FOR DETERM. CREATININE IN H/SERU

Applicant Diagnostic Solutions, Inc.

K number K800685

View details →

CGX 1980-04-02

NSI CREATININE KIT

Applicant Nobel Scientific Industries, Inc.

K number K800583

View details →

CGX 1980-02-26

SERUM CREATININE; ALK. BUFFER & PICRIC

Applicant Fisher Scientific Co., LLC

K number K800219

View details →

CGX 1979-12-07

ELVI CREATININE

Applicant Volu Sol Medical Industries

K number K792404

View details →

CGX 1979-12-07

ELVI CREATININ

Applicant Volu Sol Medical Industries

K number K792402

View details →

CGX 1979-12-07

ELVI CREATININE

Applicant Volu Sol Medical Industries

K number K792397

View details →

CGX 1979-10-17

CREATININE DIAG. REAGENT PICRIC ACID

Applicant Connecticut Diagnostics, Ltd.

K number K791994

View details →

CGX 1979-09-17

PICRIC SOLUTION

Applicant Hi Chem, Inc.

K number K791689

View details →

CGX 1979-09-17

ALKALINE BUFFER

Applicant Hi Chem, Inc.

K number K791688

View details →

CGX 1979-02-22

REAGENT KIT, BAKERS DIAGNOSTIC

Applicant J.T. Baker Chemical Co.

K number K790044

View details →

CGX 1979-01-17

HILAR

Applicant Hi Chem, Inc.

K number K782094

View details →

CGX 1978-12-20

SERUM, CREATININE DETERMINATIONS

Applicant Fisher Scientific Co., LLC

K number K781884

View details →

CGX 1978-09-14

CREATININE REAGENT SET

Applicant Nobel Scientific Industries, Inc.

K number K781396

View details →

CGX 1978-05-19

ULTRACHEM CREATININE 64972, CENTRIFUCHEM

Applicant Harleco

K number K780514

View details →

CGX 1977-12-06

CREATININE, 64972

Applicant Harleco

K number K772157

View details →

CGX 1977-11-28

CREATININE URINE APPLI.-#32308

Applicant Harleco

K number K772107

View details →

CGX 1977-11-03

DIR. QUANT. COLOR. DETERM. SERUM CREAT.

Applicant Stanbio Laboratory

K number K771856

View details →

CGX 1977-11-03

CREATININE

Applicant Gamma Enterprises, Inc.

K number K771834

View details →

CGX 1977-10-19

PROCEDURE NO. 555

Applicant Sigma Chemical Co.

K number K771916

View details →

CGX 1977-10-14

CLINICARD CREATININE CHEMISTRY

Applicant Harleco

K number K771773

View details →

CGX 1977-08-22

MULTISTAT III CREATININE TEST

Applicant Instrumentation Laboratory CO

K number K771443

View details →

CGX 1977-08-16

CREATININE ANALYSIS PRODUCTS

Applicant Abbott Laboratories

K number K771365

View details →

CGX 1977-08-03

CREATININE ANALYZER 2

Applicant Beckman Instruments, Inc.

K number K771335

View details →

CGX 1977-07-11

ULTRACHEM CREATININE

Applicant Harleco

K number K770819

View details →

CGX 1977-06-24

CREATININE TEST, SUPER SEVENTEEN

Applicant Hycel, Inc.

K number K770643

View details →

CGX 1977-05-03

CREATININE PROCEDURE, TEKPOINT

Applicant Icn Pharmaceuticals, Inc.

K number K770454

View details →

CGX 1977-02-22

REAGENT SYSTEM

Applicant American Monitor Corp.

K number K770242

View details →

CGX 1977-02-14

AUTO CREATININE REAGENT (GILFORD 3400-E)

Applicant Harleco

K number K761280

View details →

CGX 1977-02-11

AUTO CREATININE REAGENT (ABBOTT SYSTEM)

Applicant Harleco

K number K761279

View details →