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 |
|---|---|---|---|
| Dec 28, 1992 | K925668 | CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM E.I. Dupont DE Nemours & Co., Inc. | CGX |
| Oct 19, 1992 | K924692 | OLYMPUS CREATININE REAGENT Olympus Corp. | CGX |
| Oct 15, 1992 | K924599 | CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2 Em Diagnostic Systems, Inc. | CGX |
| Sep 18, 1992 | K923526 | OLYMPUS CREATININE REAGENT Olympus Corp. | CGX |
| Sep 9, 1992 | K923203 | SYSTEMATE CREATININE TEST Em Diagnostic Systems, Inc. | CGX |
| Aug 24, 1992 | K923039 | MILES URINE CREATININE METHOD Heraeus Kulzer, Inc. | CGX |
| Dec 18, 1991 | K915077 | SYNCHRON CREATININE TRIGGERED TEST CX4,5,7, Beckman Instruments, Inc. | CGX |
| Sep 18, 1991 | K913707 | ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A28 Em Diagnostic Systems, Inc. | CGX |
| May 8, 1991 | K905658 | SYSTEMATE CREATININE (EPOS APPLICATION) #65413 Em Diagnostic Systems, Inc. | CGX |
| Mar 11, 1991 | K910147 | CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED Olympus Corp. | CGX |
| Feb 13, 1991 | K905619 | CREATININE (RATE) REAGENT SET Biochemical Trade, Inc. | CGX |
| Oct 1, 1990 | K893582 | N-A-G TEST KIT Ppr Diagnostics , Ltd. | CGX |
| Sep 7, 1990 | K902561 | ROCHE COBAS READY CREATININE REAGENT Roche Diagnostic Systems, Inc. | CGX |
| Aug 17, 1990 | K903296 | SYNERMED CREATININE REAGENT KIT Synermed, Inc., CA | CGX |
| Jun 28, 1990 | K902172 | COULTER CREATININE REAGENT Coulter Corp. | CGX |
| May 4, 1990 | K901229 | CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE) Technicon Instruments Corp. | CGX |
| Apr 25, 1990 | K901298 | CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY Olympus Corp. | CGX |
| Apr 19, 1990 | K900666 | AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791 American Research Products Co. | CGX |
| Feb 8, 1990 | K896686 | AMRESCO CREATININE REAGENT #4316100 American Research Products Co. | CGX |
| Oct 30, 1989 | K895847 | CREATININE 340 (ENZYMATIC) Sclavo, Inc. | CGX |
| Oct 23, 1989 | K895022 | SYSTEMATE CREATININE TEST (CREA) #65413 Em Diagnostic Systems, Inc. | CGX |
| May 9, 1989 | K890671 | HI CHEM CREATININE REAGENT (PRODUCT #88809) Hichem Diagnostics | CGX |
| Dec 19, 1988 | K884734 | CREATININE TEST (CREA) ITEM #65663 Em Diagnostic Systems, Inc. | CGX |
| Jun 16, 1988 | K881856 | BIOTROL CREATININE H.P. REAGENT Biotrol, USA, Inc. | CGX |
| Apr 28, 1988 | K881400 | CREATININE FOR CONTINUOUS FLOW INSTRUMENTS Catachem, Inc. | CGX |
| Apr 5, 1988 | K880843 | CREATININE REAGENT SET (KINETIC) Tech-Neal Scientific, Inc. | CGX |
| Mar 23, 1988 | K880629 | CREATININE Tech-Co, Inc. | CGX |
| Nov 23, 1987 | K873531 | PARAMAX CREATININE REAGENT Baxter Healthcare Corp | CGX |
| Nov 6, 1987 | K874088 | EASY-TEST CREATININE (CREA) ITEM NO. 19009 Em Diagnostic Systems, Inc. | CGX |
| Oct 23, 1987 | K873131 | CREATININE REAGENT KIT A-Kem, Inc. | CGX |
| Oct 20, 1987 | K873725 | MULTICHEM CREATININE REAGENT S0917 Simmler, Inc. | CGX |
| Oct 2, 1987 | K873365 | CREATININE REAGENT Sigma Diagnostics, Inc. | CGX |
| Sep 2, 1987 | K873310 | ABBOTT SPECTRUM(R) LIQUID CREATININE REAGENT Abbott Laboratories | CGX |
| Aug 28, 1987 | K872310 | CURAD MEDICATED PLASTIC STRIPS The Kendal Co. | CGX |
| Aug 19, 1987 | K870366 | CREATININE REAGENT - PICRIC ACID METHOD Trace Scientific , Ltd., AU | CGX |
| Dec 12, 1986 | K863079 | CREATINKINETIC J. D. Assoc. | CGX |
| Nov 5, 1986 | K863738 | EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95 Em Diagnostic Systems, Inc. | CGX |
| Oct 2, 1986 | K863261 | CREATININE PROCEDURE Data Medical Associates, Inc. | CGX |
| Jul 1, 1986 | K861655 | CREATININE PROCEDURE Data Medical Associates, Inc. | CGX |
| Jun 11, 1986 | K861819 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CREA) Eastman Kodak Company | CGX |
| Feb 11, 1986 | K860418 | CREATININE REAGENT SET Sterling Diagnostics, Inc. | CGX |
| Jan 14, 1986 | K855193 | CREATININE REAGENT SET Technostics Intl. | CGX |
| Jan 13, 1986 | K854846 | VISION CREATININE Abbott Laboratories | CGX |
| Nov 25, 1985 | K854178 | IN-VITRO TEST FOR THE DETERMINATION OF CREATININE Clinical Data, Inc. | CGX |
| Oct 15, 1985 | K853888 | AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 & American Research Products Co. | CGX |
| Jul 12, 1985 | K852565 | TECHNICON CHEMI Technicon Instruments Corp. | CGX |
| Jun 25, 1985 | K850932 | CREATININE Dilab, Inc. | CGX |
| May 30, 1985 | K851993 | CRE BUFFER CRE DYE Alpkem Corp. | CGX |
| May 20, 1985 | K851849 | CREATINE LIQUID STABLE REAGENT SET Medical Analysis Systems, Inc. | CGX |
| Jan 3, 1985 | K844332 | CREATININE REAGENT FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. | CGX |
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