CFR — Hexokinase, Glucose Class II
FDA product code CFR covers "Hexokinase, Glucose", a Class II medical device regulated under 21 CFR 862.1345. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CFR
- Device Class
- Class II
- Regulation Number
- 862.1345
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253490 | roche diagnostics | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | February 12, 2026 |
| K252357 | abbott ireland | Glucose2 | October 24, 2025 |
| K220134 | roche diagnostics | cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ON | September 16, 2022 |
| K191899 | roche diagnostics | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated s | August 16, 2019 |
| K170316 | abbott laboratories | ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM | October 19, 2017 |
| K153644 | elitechgroup | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITe | September 7, 2016 |
| K151487 | diatron u.s | Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose He | January 14, 2016 |
| K131189 | beckman coulter | UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) | April 17, 2014 |
| K123018 | alfa wassermann diagnostic technologies | ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELEC | April 23, 2013 |
| K120681 | siemens healthcare diagnostics | ADVIA CHEMISTRY GLUH_3 REAGENTS | May 15, 2012 |
| K120369 | hitachi chemical diagnostics | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU) | May 10, 2012 |
| K112377 | shenzhen mindray bio-medical electronics co | BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER | March 23, 2012 |
| K113131 | ams | LIASYS 450 | March 8, 2012 |
| K103531 | tokyo boeki medisys | PRESTIGE 24I; BIOLIS 24I; MGC 240 | December 1, 2011 |
| K103788 | horiba abx | PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT | November 8, 2011 |
| K101854 | siemens healthcare diagnostics | ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429 | March 7, 2011 |
| K092603 | roche diagnostics | COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY | December 4, 2009 |
| K090703 | polymedco | POLY-CHEM 90 GLUCOSE | October 20, 2009 |
| K092506 | medica | EASYRA GLU-H REAGENT, MODEL 10200 | September 16, 2009 |
| K081276 | horiba abx | ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H | September 12, 2008 |