510(k) K220134
- Device
- Cobas Pure Integrated Solutions, Glucose HK Gen.3, ISE Indirect Na For Gen.2, ONLINE DAT Methadone II, Elecsys TSH
- Applicant
- Roche Diagnostics
- 510(k) number
- K220134
- Product code
- CFR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-09-16
- Date received
- 2022-01-18
- Regulation
- 862.1345
- Classification name
- Hexokinase, Glucose
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Noel Mencias
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 3013660430
- 3007603826
- 8020316
- 3006198300
- 1063851
- 3016244760
- 3003795116
- 2030861
- 1181121
- 3009156722
- 9614673
- 9680746
- 2050012
- 3006716639
- 3005333358
- 9610529
- 3010324880
- 2432235
- 1832216
- 3002809144
- 9614698
- 2517506
- 2247288
- 3020917535
- 3007662974
- 1827821
- 3011989923
- 3004493545
- 1415939
- 3016438761
- 2050010
- 3010825766
- 2032900
- 1000256526
- 2085064
- 1616487
- 3004378326
- 9610126
- 1220972
- 3004438098
- 9610942
- 2221819
- 3009880320
- 3000148879
- 3004192065
Source Documents#
Other 510(k) Records For Product Code CFR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | Roche Diagnostics | 2026-02-12 |
| K252357 | Glucose2 | Abbott Ireland | 2025-10-24 |
| K191899 | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions | Roche Diagnostics | 2019-08-16 |
| K170316 | ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM | Abbott Laboratories | 2017-10-19 |
| K153644 | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II | Elitechgroup | 2016-09-07 |
| K151487 | Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method | Diatron U.S., Inc. | 2016-01-14 |
| K131189 | UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) | Beckman Coulter, Inc. | 2014-04-17 |
| K123018 | ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE | Alfa Wassermann Diagnostic Technologies, Inc. | 2013-04-23 |
| K120681 | ADVIA CHEMISTRY GLUH_3 REAGENTS | Siemens Healthcare Diagnostics, Inc. | 2012-05-15 |
| K120369 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU) | Hitachi Chemical Diagnostics, Inc. | 2012-05-10 |
| K112377 | BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012-03-23 |
| K113131 | LIASYS 450 | Ams | 2012-03-08 |
| K103531 | PRESTIGE 24I; BIOLIS 24I; MGC 240 | Tokyo Boeki Medisys, Inc. | 2011-12-01 |
| K103788 | PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT | HORIBA ABX SAS | 2011-11-08 |
| K101854 | ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429 | Siemens Healthcare Diagnostics | 2011-03-07 |
Legacy Summary#
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FDA Review#
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