FDA Product Code
FDA Product Code CFR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1345
510(k) Clearances — 145 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K855153 | GLUCOSE (UV HEXOKIASE) REAGENT SET | Technostics Intl. | 1986-01-14 | Traditional | PDF ↗ |
| K853826 | GLUCOSE HEXOKINASE FOR CONTINUOUS FLOW INSTRUMENTS | Catachem, Inc. | 1985-09-30 | Traditional | PDF ↗ |
| K853464 | GLUCOSE SR LIQUID STABLE REAGENT SET | Medical Analysis Systems, Inc. | 1985-09-04 | Traditional | PDF ↗ |
| K844998 | GLUCOSE(HEXOKINASE) REAGENT SET | Sterling Biochemical, Inc. | 1985-01-18 | Traditional | PDF ↗ |
| K843541 | PDA GLUCOSE | Abbott Laboratories | 1984-09-28 | Traditional | PDF ↗ |
| K843150 | SYSTEMATE GLUCOSE 67216 | Em Diagnostic Systems, Inc. | 1984-08-27 | Traditional | PDF ↗ |
| K842510 | GLUCOSE ASSAY KIT-HEXOKINASE | Diagnostic Chemicals, Ltd. (Usa) | 1984-07-20 | Traditional | PDF ↗ |
| K841555 | SIGMA PROCEDURE 16-UV | Sigma Chemical Co. | 1984-05-22 | Traditional | PDF ↗ |
| K832872 | HEXOKINASE, GLUCOSE | Pointe Scientific, Inc., | 1983-10-14 | Traditional | PDF ↗ |
| K831560 | GLUCOSE HEXOKINASE DIAG. KIT | Sclavo, Inc. | 1983-07-06 | Traditional | PDF ↗ |
| K821868 | ULTRACHEM E-GLU | Harleco Diagnostics | 1982-07-08 | Traditional | PDF ↗ |
| K821475 | ULTRACHEM E-GLU #64976&65040 | Emd Chemicals, Inc. | 1982-06-25 | Traditional | PDF ↗ |
| K821461 | ULTRACHEM E-GLU, #64976 & 65040 | Emd Chemicals, Inc. | 1982-06-02 | Traditional | PDF ↗ |
| K821470 | ULTRACHEM E-GLU #64976 & 65040 | Emd Chemicals, Inc. | 1982-06-02 | Traditional | PDF ↗ |
| K812595 | ULTRA CHEM E-GLU #64976 & 65040 | Harleco | 1981-09-29 | Traditional | PDF ↗ |
| K812303 | GLUCOSE-HK SYSTEM PACK TEST | Boehringer Mannheim Corp. | 1981-09-01 | Traditional | PDF ↗ |
| K811849 | ESKAFLOW TEST FOR GLUCOSE | Smithkline Diagnostics, Inc. | 1981-07-15 | Traditional | PDF ↗ |
| K802810 | HEXOKINASE, GLUCOSE | Beckman Instruments, Inc. | 1980-12-10 | Traditional | PDF ↗ |
| K801456 | F/LS MCA APPLICATION SOFTWARE | Instrumentation Laboratory CO | 1980-10-03 | Traditional | PDF ↗ |
| K801765 | GLUCOSE REAGENT(UV-HEXOKINASE) | Reagents Applications, Inc. | 1980-09-16 | Traditional | PDF ↗ |
| K801297 | COBAS REAGENT FOR GLUCOSE RAPID | Roche Analytical Instruments, Inc. | 1980-06-30 | Traditional | PDF ↗ |
| K801051 | DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI | Data Medical Associates, Inc. | 1980-05-23 | Traditional | PDF ↗ |
| K801052 | DATA-ZYME GLUCOSE HEXOKINASE UV | Data Medical Associates, Inc. | 1980-05-23 | Traditional | PDF ↗ |
| K792532 | GLUCOSE (HEXOKINASE) REAGENT SET | Macomb Chemical Co. | 1980-01-11 | Traditional | PDF ↗ |
| K791760 | GLUCOSE HEXOKINASE COIL REAGENT SYSTEM | Fisher Scientific Co., LLC | 1979-09-27 | Traditional | PDF ↗ |
| K790786 | GLUCOSE (HK) REAGENT | Gilford Diagnostics | 1979-06-15 | Traditional | PDF ↗ |
| K782136 | GLUCOSE REAGENT SYSTEM | American Monitor Corp. | 1979-01-26 | Traditional | PDF ↗ |
| K781723 | GLUCOSE HEXOKINASE, AUTO K | Medical Analysis Systems, Inc. | 1978-11-03 | Traditional | PDF ↗ |
| K780858 | PRINCETON BIOMEDIX HEXOKINASE, GLUCOSE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-06-22 | Traditional | PDF ↗ |
| K780515 | ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM | Harleco | 1978-05-19 | Traditional | PDF ↗ |
| K780072 | GLUCOSE REAGENT SET | Medical Analysis Systems, Inc. | 1978-02-14 | Traditional | PDF ↗ |
| K780065 | ULTRACHEM E-GLU, MANUAL DETERM. | Harleco | 1978-02-01 | Traditional | PDF ↗ |
| K771464 | MULTISTAT III GLUCOSE TEST | Instrumentation Laboratory CO | 1977-09-02 | Traditional | PDF ↗ |
| K771384 | AUTOZYME IMMOBILIZED ENZYME COIL | Technicon Instruments Corp. | 1977-08-22 | Traditional | PDF ↗ |
| K771311 | GLUCOSE REAGENT (HEXOHINASE) | Mallinckrodt Critical Care | 1977-08-03 | Traditional | PDF ↗ |
| K770844 | FLUCOSE U.V. TEST KIT | Mallinckrodt Critical Care | 1977-07-14 | Traditional | PDF ↗ |
| K770886 | AUTO-ENZYMATIC GLUCOSE FOR ANALYZER | Harleco | 1977-07-14 | Traditional | PDF ↗ |
| K770311 | GLUCOSE REAGENT, ENZYMATIC | Icn Pharmaceuticals, Inc. | 1977-03-30 | Traditional | PDF ↗ |
| K770229 | AUTO-ENZYMATIC GLUCOSE | Harleco | 1977-03-01 | Traditional | PDF ↗ |
| K770262 | GLUCOSE (HEXOKINASE) DELTA TEST ASSAY | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-02-23 | Traditional | PDF ↗ |
| K761320 | GLUCOSE KIT | Environmental Chemical Specialties | 1977-01-25 | Traditional | PDF ↗ |
| K761345 | GLUCO-HEX TM REAGENT KIT | J.T. Baker Chemical Co. | 1977-01-05 | Traditional | PDF ↗ |
| K761240 | AUTO-ENZYMATIC GLUCOSE | Harleco | 1976-12-29 | Traditional | PDF ↗ |
| K760247 | GLUCOSE REAGENT SYS, SIGMA PROCED. 115 | Sigma Chemical Co. | 1976-08-26 | Traditional | PDF ↗ |
| K760055 | REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER | Smithkline Diagnostics, Inc. | 1976-08-26 | Traditional | PDF ↗ |
Product code CFR · Class II · Clinical Chemistry. Data: openFDA.