510(k) K032311
- Device
- ROCHE DIAGNOSTICS OMNI S ANALYZER
- Applicant
- ROCHE DIAGNOSTICS CORP.
- 510(k) number
- K032311
- Product code
- CEM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-10-17
- Date received
- 2003-07-28
- Regulation
- 862.1600
- Classification name
- Electrode, Ion Specific, Potassium
- 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
- JENNIFER TRIBBETT
- Address
- P.O. Box 50457 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 3003795116
- 3003030793
- 9680746
- 2432235
- 9610529
- 3009473156
- 3007662974
- 1717966
- 3002807968
- 3016438761
- 3013513377
- 2085064
- 8020888
- 1319681
- 1219029
- 3000308930
- 3004102403
- 3000148879
- 2431530
- 9610633
- 3005509212
- 9610816
- 3005333358
- 1319809
- 1217183
- 3023268435
- 3002809144
- 2247288
- 3005643513
- 3004493545
- 3007490412
- 3010825766
- 1000256526
- 1220649
- 3009880320
- 3003593973
- 3007603826
- 8020316
- 3016244760
- 9614673
- 2050012
- 3010324880
- 2250051
- 3003971136
- 1036362
- 2517506
- 3011989923
- 3002637618
- 3003637681
- 2939693
- 3002642396
- 2050010
- 3012817228
- 1219913
- 3008244372
- 1036223
- 3000126629
- 3014506106
- 1000455123
- 3006198300
- 2030861
- 1181121
- 3009156722
- 9612296
- 8030478
- 1319436
- 3012963943
- 1317202
- 3004959793
- 1827821
- 3014607865
- 2245578
- 3037000637
- 1222035
- 1616487
- 1000414342
- 3004378326
- 9610126
- 1220972
- 3004438098
Source Documents#
Other 510(k) Records For Product Code CEM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions | Roche Diagnostics | 2026-02-12 |
| K241037 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | 2025-01-14 |
| K220396 | EasyStat 300 | Medica Corporation | 2023-09-26 |
| K230890 | ISE Electrodes | Randox Laboratories, Ltd. | 2023-09-08 |
| K200544 | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ | Diamond Diagnostics, Inc. | 2020-10-01 |
| K121012 | FLEXLAB 3.6, ACCELERATOR A3600 | Inpeco S.P.A. | 2012-08-31 |
| K121040 | SMARTLYTE ELECTROLYTE ANALYZER | Diamond Diagnostics, Inc. | 2012-08-30 |
| K112995 | GEM PREMIER 4000 | Instrumentation Laboratory CO | 2012-05-03 |
| K110520 | BIOLIS 12I | Tokyo Boeki Medisys, Inc. | 2012-03-23 |
| K112412 | AU5800(R) CHEMISTRY ANALYZER | Beckman Coulter, Inc. | 2011-12-23 |
| K112408 | POLY-CHEM 90 ISE MODULE | Polymedco, Inc. | 2011-11-04 |
| K112788 | EASTLYTE NA/K/CA/PH | Medica Corp. | 2011-10-20 |
| K092686 | ABL90 FLEX SERIES | Radiometer Medical Aps | 2010-08-06 |
| K092849 | BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER | Epocal, Inc. | 2010-03-30 |
| K093318 | ACCELERATOR APS | Abbott Laboratories | 2010-02-19 |
Legacy Summary#
summary
FDA Review#
Decision Summary