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 |
|---|---|---|---|
| Oct 30, 1984 | K844024 | CREATININE REAGENT SET Livonia Diagnostics, Inc. | CGX |
| Oct 30, 1984 | K843916 | TDX REA CREATININE Abbott Laboratories | CGX |
| Sep 28, 1984 | K843377 | CREATININE ASSAY KIT Diagnostic Chemicals, Ltd. (Usa) | CGX |
| Sep 7, 1984 | K843179 | CREATININE TEST Sclavo, Inc. | CGX |
| Aug 27, 1984 | K843105 | SYSTEMATE CREATININE 67223 Em Diagnostic Systems, Inc. | CGX |
| Aug 16, 1984 | K842159 | CREATININE ASSAY KIT-KINETIC OR ENDPOINT Diagnostic Chemicals, Ltd. (Usa) | CGX |
| May 11, 1984 | K841377 | CREATININE - A.A.S. Advanced Analytical Systems, Inc. | CGX |
| Apr 18, 1984 | K840872 | RAICHEM CREATININE REAGENT Reagents Applications, Inc. | CGX |
| Jan 17, 1984 | K832439 | CREATININE REAGENT SET Amresco, Inc. | CGX |
| Jul 6, 1983 | K831628 | CREATININE REAGENTS B6370-13 American Scientific Products | CGX |
| Jul 6, 1983 | K831627 | CREATININE REAGENTS B6360-10 American Scientific Products | CGX |
| Mar 24, 1983 | K830556 | CREATININE Pointe Scientific, Inc., | CGX |
| Mar 24, 1983 | K830537 | FLOW-PAC CREATININE REAGENT SET Amresco, Inc. | CGX |
| Mar 24, 1983 | K830447 | KINETIC CREATININE American Monitor Corp. | CGX |
| Jan 14, 1983 | K823806 | DIRECT CREATININE PROCEDURE Analytical & Research Chemicals, Inc. | CGX |
| Jan 7, 1983 | K823573 | COBAS REAGENT FOR CREATININE Hoffmann-La Roche, Inc. | CGX |
| Jan 7, 1983 | K823572 | COBAS STANDARDS FOR CREATININE Hoffmann-La Roche, Inc. | CGX |
| Sep 30, 1982 | K822118 | FERMCOTEST CREATININE TEST REAGENT Fermco Biochemics, Inc. | CGX |
| Jul 14, 1982 | K821881 | ULTRACHEM CREA Harleco Diagnostics | CGX |
| Jul 13, 1982 | K821199 | CREATININE REAGENT SET Omega Medical Electronics | CGX |
| Jan 29, 1982 | K813560 | LIQUIZYME CREATININE REAGENT SET Amresco, Inc. | CGX |
| Jan 26, 1982 | K820075 | SERALYZER CREATININE REAGENT STRIPS Miles Laboratories, Inc. | CGX |
| Dec 3, 1981 | K812834 | CREATININE REAGENT SET Anco Medical Reagents & Assoc. | CGX |
| Nov 10, 1981 | K813043 | ULTRACHEM CREA ITEM #64972 Harleco | CGX |
| Aug 13, 1981 | K812109 | GILCHEM CREATININE REAGENT Gilford Diagnostics | CGX |
| Aug 13, 1981 | K811406 | CREATININE RATE REAGENT KIT Chem-Elec, Inc. | CGX |
| Jun 26, 1981 | K811659 | CREATININE REAGENT Gilford Diagnostics | CGX |
| Jun 25, 1981 | K811664 | CREATININE TEST King Diagnostics, Inc. | CGX |
| Jan 2, 1981 | K803087 | LANCER CREATININE MICROSAMPLE STAT ANA Sherwood Medical Co. | CGX |
| Oct 10, 1980 | K802156 | REAGENTS SERUM CREATINE USING TECHICON Panmed, Inc. | CGX |
| May 28, 1980 | K800685 | REAGENT FOR DETERM. CREATININE IN H/SERU Diagnostic Solutions, Inc. | CGX |
| Apr 2, 1980 | K800583 | NSI CREATININE KIT Nobel Scientific Industries, Inc. | CGX |
| Feb 26, 1980 | K800219 | SERUM CREATININE; ALK. BUFFER & PICRIC Fisher Scientific Co., LLC | CGX |
| Dec 7, 1979 | K792404 | ELVI CREATININE Volu Sol Medical Industries | CGX |
| Dec 7, 1979 | K792402 | ELVI CREATININ Volu Sol Medical Industries | CGX |
| Dec 7, 1979 | K792397 | ELVI CREATININE Volu Sol Medical Industries | CGX |
| Oct 17, 1979 | K791994 | CREATININE DIAG. REAGENT PICRIC ACID Connecticut Diagnostics, Ltd. | CGX |
| Sep 17, 1979 | K791689 | PICRIC SOLUTION Hi Chem, Inc. | CGX |
| Sep 17, 1979 | K791688 | ALKALINE BUFFER Hi Chem, Inc. | CGX |
| Feb 22, 1979 | K790044 | REAGENT KIT, BAKERS DIAGNOSTIC J.T. Baker Chemical Co. | CGX |
| Jan 17, 1979 | K782094 | HILAR Hi Chem, Inc. | CGX |
| Dec 20, 1978 | K781884 | SERUM, CREATININE DETERMINATIONS Fisher Scientific Co., LLC | CGX |
| Sep 14, 1978 | K781396 | CREATININE REAGENT SET Nobel Scientific Industries, Inc. | CGX |
| May 19, 1978 | K780514 | ULTRACHEM CREATININE 64972, CENTRIFUCHEM Harleco | CGX |
| Dec 6, 1977 | K772157 | CREATININE, 64972 Harleco | CGX |
| Nov 28, 1977 | K772107 | CREATININE URINE APPLI.-#32308 Harleco | CGX |
| Nov 3, 1977 | K771856 | DIR. QUANT. COLOR. DETERM. SERUM CREAT. Stanbio Laboratory | CGX |
| Nov 3, 1977 | K771834 | CREATININE Gamma Enterprises, Inc. | CGX |
| Oct 19, 1977 | K771916 | PROCEDURE NO. 555 Sigma Chemical Co. | CGX |
| Oct 14, 1977 | K771773 | CLINICARD CREATININE CHEMISTRY Harleco | CGX |
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