Product Code: CFR
FDA class 2
21 CFR 862.1345
Hexokinase, Glucose
Clinical Chemistry
The Hexokinase, Glucose test system (product code CFR) is an in-vitro diagnostic device used in clinical chemistry to measure glucose concentrations in biological specimens using the hexokinase enzymatic method, which is a widely accepted reference technique for glucose quantification. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1345 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
510(k)s
143
FEI Numbers
48
Registration Numbers
48
Unique Applicants
87
Years Active
46
Basic Information
- Product Code
- CFR
- Device Class
- FDA class 2
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 143 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K220134 | cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH | Sep 16, 2022 | Substantially Equivalent | Roche Diagnostics |
| K191899 | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions | Aug 16, 2019 | Substantially Equivalent | Roche Diagnostics |
| K170316 | ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM | Oct 19, 2017 | Substantially Equivalent | Abbott Laboratories |
| K153644 | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II | Sep 07, 2016 | Substantially Equivalent | ELITechGroup |
| K151487 | Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method | Jan 14, 2016 | Substantially Equivalent | Diatron US, Inc. |
| K131189 | UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) | Apr 17, 2014 | Substantially Equivalent | BECKMAN COULTER, INC. |
| K123018 | ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE | Apr 23, 2013 | Substantially Equivalent | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K120681 | ADVIA CHEMISTRY GLUH_3 REAGENTS | May 15, 2012 | Substantially Equivalent | Siemens Healthcare Diagnostics Inc. |
| K120369 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU) | May 10, 2012 | Substantially Equivalent | HITACHI CHEMICAL DIAGNOSTICS, INC. |
| K112377 | BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER | Mar 23, 2012 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K113131 | LIASYS 450 | Mar 08, 2012 | Substantially Equivalent | AMS |
| K103531 | PRESTIGE 24I; BIOLIS 24I; MGC 240 | Dec 01, 2011 | Substantially Equivalent | TOKYO BOEKI MEDISYS INC. |
| K103788 | PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT | Nov 08, 2011 | Substantially Equivalent | HORIBA ABX SAS |
| K101854 | ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429 | Mar 07, 2011 | Substantially Equivalent | SIEMENS HEALTHCARE DIAGNOSTICS |
| K092603 | COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY | Dec 04, 2009 | Substantially Equivalent | Roche Diagnostics |
| K090703 | POLY-CHEM 90 GLUCOSE | Oct 20, 2009 | Substantially Equivalent | POLYMEDCO, INC. |
| K092506 | EASYRA GLU-H REAGENT, MODEL 10200 | Sep 16, 2009 | Substantially Equivalent | MEDICA CORP. |
| K081276 | ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H | Sep 12, 2008 | Substantially Equivalent | HORIBA ABX |
| K080468 | LIASYS WITH MODELS LIASYS | Jul 25, 2008 | Substantially Equivalent | AMS S.R.L. ANALYZER MEDICAL SYSTEM |
| K080123 | APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 | Jul 17, 2008 | Substantially Equivalent | WAKO CHEMICALS USA, INC. |
| K072140 | S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU | Jun 24, 2008 | Substantially Equivalent | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K072018 | BS-200 CHEMISTRY ANALYZER, MODE BS-200 | Feb 01, 2008 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K062118 | POINTE 360 | Jul 13, 2007 | Substantially Equivalent | POINTE SCIENTIFIC, INC. |
| K061879 | SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM | Dec 15, 2006 | Substantially Equivalent | HEMODIAGNOSTICA, LLC |
| K062239 | GLUCOSE HK NEW FORMULATION TEST SYSTEM | Sep 11, 2006 | Substantially Equivalent | ROCHE DIAGNOSTICS CORP. |
| K061048 | COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM | May 17, 2006 | Substantially Equivalent | ROCHE DIAGNOSTICS CORP. |
| K060383 | GLUCOSE | May 05, 2006 | Substantially Equivalent | ABBOTT LABORATORIES |
| K060256 | UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM | Feb 27, 2006 | Substantially Equivalent | BECKMAN COULTER, INC. |
| K052007 | ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE) | Dec 16, 2005 | Substantially Equivalent | HORIBA ABX |
| K052163 | ADVIA IMS GLUCOSE ASSAY | Oct 11, 2005 | Substantially Equivalent | BAYER HEALTHCARE, LLC |
| K042767 | DATAPRO CLINICAL CHELISTRY ANALYZER | Apr 27, 2005 | Substantially Equivalent | THERMO ELECTRON CORPORATION |
| K041052 | RAICHEM GLUCOSE UV (LIQUID) | Jun 30, 2004 | Substantially Equivalent | HEMAGEN DIAGNOSTICS, INC. |
| K031135 | GLUCOSE FLEX REAGENT CARTRIDGE (GLUC) | Jun 02, 2003 | Substantially Equivalent | DADE BEHRING, INC. |
| K024281 | WAKO L-TYPE GLUCOSE 2 | Feb 24, 2003 | Substantially Equivalent | WAKO CHEMICALS, USA, INC. |
| K023739 | GLUCOSE-SL-C ASSAY, MODEL 257-30 | Jan 17, 2003 | Substantially Equivalent | DIAGNOSTIC CHEMICALS LTD. |
| K020852 | POLY-CHEM GLUCOSE | Jul 03, 2002 | Substantially Equivalent | POLYMEDCO, INC. |
| K011963 | ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY | Nov 20, 2001 | Substantially Equivalent | BAYER CORP. |
| K012668 | RAICHEM GLUCOSE UV REAGENT | Oct 15, 2001 | Substantially Equivalent | HEMAGEN DIAGNOSTICS, INC. |
| K011900 | GLUCOSE (HEXOKINASE) | Jul 31, 2001 | Substantially Equivalent | JAS Diagnostics, Inc. |
| K002199 | MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET | Nov 20, 2000 | Substantially Equivalent | POINTE SCIENTIFIC, INC. |
| K001403 | SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P | Aug 10, 2000 | Substantially Equivalent | SIGMA DIAGNOSTICS, INC. |
| K000556 | ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS | May 17, 2000 | Substantially Equivalent | ELAN DIAGNOSTICS |
| K000102 | GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150 | Feb 08, 2000 | Substantially Equivalent | TECO DIAGNOSTICS |
| K990981 | GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02 | May 25, 1999 | Substantially Equivalent | A.P. TOTAL CARE, INC. |
| K984574 | INFINITY GLUCOSE REAGENT | Feb 11, 1999 | Substantially Equivalent | SIGMA DIAGNOSTICS, INC. |
| K980883 | N-ASSAY GLU-UL | Sep 03, 1998 | Substantially Equivalent | CRESTAT DIAGNOSTICS, INC. |
| K981185 | GLU | May 07, 1998 | Substantially Equivalent | ABBOTT LABORATORIES |
| K980026 | GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | Mar 10, 1998 | Substantially Equivalent | TRACE AMERICA, INC. |
| K970664 | GLUCOSE REAGENT | Aug 01, 1997 | Substantially Equivalent | DERMA MEDIA LAB., INC. |
| K971754 | LIQUID GLUCOSE (HEXOKINASE) REAGENT SET | Jul 22, 1997 | Substantially Equivalent | POINTE SCIENTIFIC, INC. |
| K971467 | SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU) | Jun 16, 1997 | Substantially Equivalent | CAROLINA LIQUID CHEMISTRIES CORP. |
| K971276 | GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER | Jun 16, 1997 | Substantially Equivalent | BAYER CORP. |
| K964004 | GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS | Feb 10, 1997 | Substantially Equivalent | BAYER CORP. |
| K962435 | STC AUTO-LYTE URINARY GLUCOSE ASSAY | Dec 26, 1996 | Substantially Equivalent | ORASURE TECHNOLOGIES, INC. |
| K953210 | GLUCOSE (HEXOKINASE) KIT | Oct 25, 1996 | Substantially Equivalent | RANDOX LABORATORIES, LTD. |
| K961282 | GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60 | Jun 21, 1996 | Substantially Equivalent | DIAGNOSTIC CHEMICALS LTD. |
| K960084 | HICHEM GLUCOSE/HK REAGENT KIT | Apr 04, 1996 | Substantially Equivalent | HI CHEM, INC. |
| K953847 | ROCHE REAGENT FOR GLUCOSE | Feb 13, 1996 | Substantially Equivalent | ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K952437 | DMA GLUCOSE HEXOKINASE U.V. PROCEDURE | Oct 03, 1995 | Substantially Equivalent | DATA MEDICAL ASSOCIATES, INC. |
| K951058 | GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION | Jun 01, 1995 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K945908 | GLUCOSE (HK) REAGENT (PROCEDURE NO.16) | May 08, 1995 | Substantially Equivalent | SIGMA DIAGNOSTICS, INC. |
| K944406 | OLYMPUS GLUCOSE REAGENT | Mar 15, 1995 | Substantially Equivalent | OLYMPUS AMERICA, INC. |
| K942963 | GLUCOSE QVET | Dec 29, 1994 | Substantially Equivalent | PRISMA SYSTEMS |
| K934900 | GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION | Dec 07, 1993 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K931402 | IL TEST GLUCOSE | Oct 12, 1993 | Substantially Equivalent | INSTRUMENTATION LABORATORY CO. |
| K931890 | GLUCOSE-HK TEST | Jul 22, 1993 | Substantially Equivalent | EM DIAGNOSTIC SYSTEMS, INC. |
| K926361 | GLUCOMETER ENCORE QA BLOOD GLUCOSE METER | Jun 24, 1993 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K922811 | ROCHE COBAS FUTURA GLUCOSE | Jan 27, 1993 | Substantially Equivalent | ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K924601 | OLYMPUS GLUCOSE REAGENT | Dec 03, 1992 | Substantially Equivalent | OLYMPUS CORP. |
| K924572 | EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415 | Nov 25, 1992 | Substantially Equivalent | EM DIAGNOSTIC SYSTEMS, INC. |
| K923129 | KING DIAGNOSTICS GLUCOSE (HK) REAGENT | Nov 02, 1992 | Substantially Equivalent | KING DIAGNOSTICS, INC. |
| K923018 | ENCORE TEST STRIPS | Sep 23, 1992 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K923040 | MILES URINE GLUCOSE METHOD | Sep 15, 1992 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K922232 | OLYMPUS GLUCOSE REAGENT | Jul 16, 1992 | Substantially Equivalent | OLYMPUS CORP. |
| K914794 | TECHNICON CHEM 1 PLASMA GLUCOSE | Dec 18, 1991 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K912808 | ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15 | Jul 30, 1991 | Substantially Equivalent | EM DIAGNOSTIC SYSTEMS, INC. |
| K912251 | KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST | Jul 18, 1991 | Substantially Equivalent | KING DIAGNOSTICS, INC. |
| K905227 | GLUCOSE (HK) REAGENT, UNIVERSAL | Mar 11, 1991 | Substantially Equivalent | ENZYME TECHNOLOGY, INC. |
| K905144 | ECLIPSE ICA GLUCOSE | Jan 04, 1991 | Substantially Equivalent | BIOTOPE, INC. |
| K901122 | TECHNICON CHEM 1 CLINICAL ANALYZER URINE GLUCOSE | Mar 29, 1990 | Substantially Equivalent | TECHNICON INSTRUMENTS CORP. |
| K897160 | COULTER GLUCOSE REAGENT | Mar 09, 1990 | Substantially Equivalent | COULTER ELECTRONICS, INC. |
| K896028 | GLUCOSE-HEXOKINASE REAGENTS 4470030,050,300,600 | Nov 14, 1989 | Substantially Equivalent | AMERICAN RESEARCH PRODUCTS CO. |
| K894394 | ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT | Oct 03, 1989 | Substantially Equivalent | ABBOTT LABORATORIES |
| K894483 | GLUCOSE-HK TEST (GLU-HK) ITEM #65415 | Sep 07, 1989 | Substantially Equivalent | EM DIAGNOSTIC SYSTEMS, INC. |
| K891923 | AMRESCO PRODUCT NUMBER 7426 | Jun 20, 1989 | Substantially Equivalent | AMERICAN RESEARCH PRODUCTS CO. |
| K884736 | GLUCOSE-HK TEST (GLUC-HK) ITEM #65665 | Jan 03, 1989 | Substantially Equivalent | EM DIAGNOSTIC SYSTEMS, INC. |
| K884021 | EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95 | Nov 10, 1988 | Substantially Equivalent | EM DIAGNOSTIC SYSTEMS, INC. |
| K882334 | ABBOTT SPECTRUM SIMULSTAT GLUCOSE/BUN REAGENT | Aug 09, 1988 | Substantially Equivalent | ABBOTT LABORATORIES |
| K880236 | GLUCOSE HEXOKINASE | Mar 15, 1988 | Substantially Equivalent | TECH-NEAL SCIENTIFIC, INC. |
| K874846 | GLUCOSE (HEXOKINASE) | Mar 03, 1988 | Substantially Equivalent | TECH-CO, INC. |
| K873835 | GLUCOSE-HK REAGENT | Nov 24, 1987 | Substantially Equivalent | INTERSECT SYSTEMS, INC. |
| K873936 | MODIFIED PARAMAX GLUCOSE REAGENT | Nov 23, 1987 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K871976 | MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919 | Jun 05, 1987 | Substantially Equivalent | SIMMLER, INC. |
| K871456 | ULTRA-VIOLET GLUCOSE REAGENT KIT | Apr 29, 1987 | Substantially Equivalent | BIOCHEMICAL TRADE, INC. |
| K863259 | GLUCOSE HK PROCEDURE | Sep 26, 1986 | Substantially Equivalent | DATA MEDICAL ASSOCIATES, INC. |
| K861311 | GLUCOSE (HEXOKINASE) REAGENT SET | Apr 24, 1986 | Substantially Equivalent | STERLING DIAGNOSTICS, INC. |
| K860724 | ENZYMATIC GLUCOSE REAGENT (HEXOKINASE) | Apr 07, 1986 | Substantially Equivalent | TRACE SCIENTIFIC LTD. |
| K860625 | GLUCOSE HK-60 ASSAY KIT CAT. #201-39 | Mar 17, 1986 | Substantially Equivalent | DIAGNOSTIC CHEMICALS, LTD. (USA) |
| K855153 | GLUCOSE (UV HEXOKIASE) REAGENT SET | Jan 14, 1986 | Substantially Equivalent | TECHNOSTICS INTL. |
| K853826 | GLUCOSE HEXOKINASE FOR CONTINUOUS FLOW INSTRUMENTS | Sep 30, 1985 | Substantially Equivalent | CATACHEM, INC. |
| K853464 | GLUCOSE SR LIQUID STABLE REAGENT SET | Sep 04, 1985 | Substantially Equivalent | MEDICAL ANALYSIS SYSTEMS, INC. |
| K844998 | GLUCOSE(HEXOKINASE) REAGENT SET | Jan 18, 1985 | Substantially Equivalent | STERLING BIOCHEMICAL, INC. |
| K843541 | PDA GLUCOSE | Sep 28, 1984 | Substantially Equivalent | ABBOTT LABORATORIES |
| K843150 | SYSTEMATE GLUCOSE 67216 | Aug 27, 1984 | Substantially Equivalent | EM DIAGNOSTIC SYSTEMS, INC. |
| K842510 | GLUCOSE ASSAY KIT-HEXOKINASE | Jul 20, 1984 | Substantially Equivalent | DIAGNOSTIC CHEMICALS, LTD. (USA) |
| K841555 | SIGMA PROCEDURE 16-UV | May 22, 1984 | Substantially Equivalent | SIGMA CHEMICAL CO. |
| K832872 | HEXOKINASE, GLUCOSE | Oct 14, 1983 | Substantially Equivalent | POINTE SCIENTIFIC, INC. |
| K831560 | GLUCOSE HEXOKINASE DIAG. KIT | Jul 06, 1983 | Substantially Equivalent | SCLAVO, INC. |
| K821868 | ULTRACHEM E-GLU | Jul 08, 1982 | Substantially Equivalent | HARLECO DIAGNOSTICS |
| K821475 | ULTRACHEM E-GLU #64976&65040 | Jun 25, 1982 | Substantially Equivalent | EMD CHEMICALS INC. |
| K821470 | ULTRACHEM E-GLU #64976 & 65040 | Jun 02, 1982 | Substantially Equivalent | EMD CHEMICALS INC. |
| K821461 | ULTRACHEM E-GLU, #64976 & 65040 | Jun 02, 1982 | Substantially Equivalent | EMD CHEMICALS INC. |
| K812595 | ULTRA CHEM E-GLU #64976 & 65040 | Sep 29, 1981 | Substantially Equivalent | HARLECO |
| K812303 | GLUCOSE-HK SYSTEM PACK TEST | Sep 01, 1981 | Substantially Equivalent | BOEHRINGER MANNHEIM CORP. |
| K811849 | ESKAFLOW TEST FOR GLUCOSE | Jul 15, 1981 | Substantially Equivalent | SMITH KLINE DIAGNOSTICS, INC. |
| K802810 | HEXOKINASE, GLUCOSE | Dec 10, 1980 | Substantially Equivalent | BECKMAN INSTRUMENTS, INC. |
| K801456 | F/LS MCA APPLICATION SOFTWARE | Oct 03, 1980 | Substantially Equivalent | INSTRUMENTATION LABORATORY CO. |
| K801765 | GLUCOSE REAGENT(UV-HEXOKINASE) | Sep 16, 1980 | Substantially Equivalent | REAGENTS APPLICATIONS, INC. |
| K801297 | COBAS REAGENT FOR GLUCOSE RAPID | Jun 30, 1980 | Substantially Equivalent | ROCHE ANALYTICAL INSTRUMENTS, INC. |
| K801052 | DATA-ZYME GLUCOSE HEXOKINASE UV | May 23, 1980 | Substantially Equivalent | DATA MEDICAL ASSOCIATES, INC. |
| K801051 | DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI | May 23, 1980 | Substantially Equivalent | DATA MEDICAL ASSOCIATES, INC. |
| K792532 | GLUCOSE (HEXOKINASE) REAGENT SET | Jan 11, 1980 | Substantially Equivalent | MACOMB CHEMICAL CO. |
| K791760 | GLUCOSE HEXOKINASE COIL REAGENT SYSTEM | Sep 27, 1979 | Substantially Equivalent | FISHER SCIENTIFIC CO., LLC. |
| K790786 | GLUCOSE (HK) REAGENT | Jun 15, 1979 | Substantially Equivalent | GILFORD DIAGNOSTICS |
| K782136 | GLUCOSE REAGENT SYSTEM | Jan 26, 1979 | Substantially Equivalent | AMERICAN MONITOR CORP. |
| K781723 | GLUCOSE HEXOKINASE, AUTO K | Nov 03, 1978 | Substantially Equivalent | MEDICAL ANALYSIS SYSTEMS, INC. |
| K780858 | PRINCETON BIOMEDIX HEXOKINASE, GLUCOSE | Jun 22, 1978 | Substantially Equivalent | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K780515 | ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM | May 19, 1978 | Substantially Equivalent | HARLECO |
| K780072 | GLUCOSE REAGENT SET | Feb 14, 1978 | Substantially Equivalent | MEDICAL ANALYSIS SYSTEMS, INC. |
| K780065 | ULTRACHEM E-GLU, MANUAL DETERM. | Feb 01, 1978 | Substantially Equivalent | HARLECO |
| K771464 | MULTISTAT III GLUCOSE TEST | Sep 02, 1977 | Substantially Equivalent | INSTRUMENTATION LABORATORY CO. |
| K771384 | AUTOZYME IMMOBILIZED ENZYME COIL | Aug 22, 1977 | Substantially Equivalent | TECHNICON INSTRUMENTS CORP. |
| K771311 | GLUCOSE REAGENT (HEXOHINASE) | Aug 03, 1977 | Substantially Equivalent | MALLINCKRODT CRITICAL CARE |
| K770886 | AUTO-ENZYMATIC GLUCOSE FOR ANALYZER | Jul 14, 1977 | Substantially Equivalent | HARLECO |
| K770844 | FLUCOSE U.V. TEST KIT | Jul 14, 1977 | Substantially Equivalent | MALLINCKRODT CRITICAL CARE |
| K770311 | GLUCOSE REAGENT, ENZYMATIC | Mar 30, 1977 | Substantially Equivalent | ICN PHARMACEUTICALS, INC. |
| K770229 | AUTO-ENZYMATIC GLUCOSE | Mar 01, 1977 | Substantially Equivalent | HARLECO |
| K770262 | GLUCOSE (HEXOKINASE) DELTA TEST ASSAY | Feb 23, 1977 | Substantially Equivalent | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K761320 | GLUCOSE KIT | Jan 25, 1977 | Substantially Equivalent | ENVIRONMENTAL CHEMICAL SPECIALTIES |
| K761345 | GLUCO-HEX TM REAGENT KIT | Jan 05, 1977 | Substantially Equivalent | J.T. BAKER CHEMICAL CO. |
| K761240 | AUTO-ENZYMATIC GLUCOSE | Dec 29, 1976 | Substantially Equivalent | HARLECO |
| K760247 | GLUCOSE REAGENT SYS, SIGMA PROCED. 115 | Aug 26, 1976 | Substantially Equivalent | SIGMA CHEMICAL CO. |
| K760055 | REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER | Aug 26, 1976 | Substantially Equivalent | SMITH KLINE DIAGNOSTICS, INC. |
FEI Numbers
This FDA classification entry is associated with 48 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 48 registration numbers. Click on an entry to view related FDA registrations.