Panels › Clinical Chemistry › Product code CFR · Class 2
Hexokinase, Glucose
Regulation 862.1345
1510(k)s in 12 months (145 all time)
0recalls in 12 months (22 all time)
21recalls that name a 510(k)
Top companies in CFR
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 14, 1986 | K855153 | GLUCOSE (UV HEXOKIASE) REAGENT SET Technostics Intl. | CFR |
| Sep 30, 1985 | K853826 | GLUCOSE HEXOKINASE FOR CONTINUOUS FLOW INSTRUMENTS Catachem, Inc. | CFR |
| Sep 4, 1985 | K853464 | GLUCOSE SR LIQUID STABLE REAGENT SET Medical Analysis Systems, Inc. | CFR |
| Jan 18, 1985 | K844998 | GLUCOSE(HEXOKINASE) REAGENT SET Sterling Biochemical, Inc. | CFR |
| Sep 28, 1984 | K843541 | PDA GLUCOSE Abbott Laboratories | CFR |
| Aug 27, 1984 | K843150 | SYSTEMATE GLUCOSE 67216 Em Diagnostic Systems, Inc. | CFR |
| Jul 20, 1984 | K842510 | GLUCOSE ASSAY KIT-HEXOKINASE Diagnostic Chemicals, Ltd. (Usa) | CFR |
| May 22, 1984 | K841555 | SIGMA PROCEDURE 16-UV Sigma Chemical Co. | CFR |
| Oct 14, 1983 | K832872 | HEXOKINASE, GLUCOSE Pointe Scientific, Inc., | CFR |
| Jul 6, 1983 | K831560 | GLUCOSE HEXOKINASE DIAG. KIT Sclavo, Inc. | CFR |
| Jul 8, 1982 | K821868 | ULTRACHEM E-GLU Harleco Diagnostics | CFR |
| Jun 25, 1982 | K821475 | ULTRACHEM E-GLU #64976&65040 Emd Chemicals, Inc. | CFR |
| Jun 2, 1982 | K821470 | ULTRACHEM E-GLU #64976 & 65040 Emd Chemicals, Inc. | CFR |
| Jun 2, 1982 | K821461 | ULTRACHEM E-GLU, #64976 & 65040 Emd Chemicals, Inc. | CFR |
| Sep 29, 1981 | K812595 | ULTRA CHEM E-GLU #64976 & 65040 Harleco | CFR |
| Sep 1, 1981 | K812303 | GLUCOSE-HK SYSTEM PACK TEST Boehringer Mannheim Corp. | CFR |
| Jul 15, 1981 | K811849 | ESKAFLOW TEST FOR GLUCOSE Smithkline Diagnostics, Inc. | CFR |
| Dec 10, 1980 | K802810 | HEXOKINASE, GLUCOSE Beckman Instruments, Inc. | CFR |
| Oct 3, 1980 | K801456 | F/LS MCA APPLICATION SOFTWARE Instrumentation Laboratory CO | CFR |
| Sep 16, 1980 | K801765 | GLUCOSE REAGENT(UV-HEXOKINASE) Reagents Applications, Inc. | CFR |
| Jun 30, 1980 | K801297 | COBAS REAGENT FOR GLUCOSE RAPID Roche Analytical Instruments, Inc. | CFR |
| May 23, 1980 | K801052 | DATA-ZYME GLUCOSE HEXOKINASE UV Data Medical Associates, Inc. | CFR |
| May 23, 1980 | K801051 | DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI Data Medical Associates, Inc. | CFR |
| Jan 11, 1980 | K792532 | GLUCOSE (HEXOKINASE) REAGENT SET Macomb Chemical Co. | CFR |
| Sep 27, 1979 | K791760 | GLUCOSE HEXOKINASE COIL REAGENT SYSTEM Fisher Scientific Co., LLC | CFR |
| Jun 15, 1979 | K790786 | GLUCOSE (HK) REAGENT Gilford Diagnostics | CFR |
| Jan 26, 1979 | K782136 | GLUCOSE REAGENT SYSTEM American Monitor Corp. | CFR |
| Nov 3, 1978 | K781723 | GLUCOSE HEXOKINASE, AUTO K Medical Analysis Systems, Inc. | CFR |
| Jun 22, 1978 | K780858 | PRINCETON BIOMEDIX HEXOKINASE, GLUCOSE Bd Becton Dickinson Vacutainer Systems Preanalytic | CFR |
| May 19, 1978 | K780515 | ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM Harleco | CFR |
| Feb 14, 1978 | K780072 | GLUCOSE REAGENT SET Medical Analysis Systems, Inc. | CFR |
| Feb 1, 1978 | K780065 | ULTRACHEM E-GLU, MANUAL DETERM. Harleco | CFR |
| Sep 2, 1977 | K771464 | MULTISTAT III GLUCOSE TEST Instrumentation Laboratory CO | CFR |
| Aug 22, 1977 | K771384 | AUTOZYME IMMOBILIZED ENZYME COIL Technicon Instruments Corp. | CFR |
| Aug 3, 1977 | K771311 | GLUCOSE REAGENT (HEXOHINASE) Mallinckrodt Critical Care | CFR |
| Jul 14, 1977 | K770886 | AUTO-ENZYMATIC GLUCOSE FOR ANALYZER Harleco | CFR |
| Jul 14, 1977 | K770844 | FLUCOSE U.V. TEST KIT Mallinckrodt Critical Care | CFR |
| Mar 30, 1977 | K770311 | GLUCOSE REAGENT, ENZYMATIC Icn Pharmaceuticals, Inc. | CFR |
| Mar 1, 1977 | K770229 | AUTO-ENZYMATIC GLUCOSE Harleco | CFR |
| Feb 23, 1977 | K770262 | GLUCOSE (HEXOKINASE) DELTA TEST ASSAY Bd Becton Dickinson Vacutainer Systems Preanalytic | CFR |
| Jan 25, 1977 | K761320 | GLUCOSE KIT Environmental Chemical Specialties | CFR |
| Jan 5, 1977 | K761345 | GLUCO-HEX TM REAGENT KIT J.T. Baker Chemical Co. | CFR |
| Dec 29, 1976 | K761240 | AUTO-ENZYMATIC GLUCOSE Harleco | CFR |
| Aug 26, 1976 | K760247 | GLUCOSE REAGENT SYS, SIGMA PROCED. 115 Sigma Chemical Co. | CFR |
| Aug 26, 1976 | K760055 | REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER Smithkline Diagnostics, Inc. | CFR |
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