510(k) K101456
- Device
- ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM
- Applicant
- Roche Diagnostics
- 510(k) number
- K101456
- Product code
- JIX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-09-08
- Date received
- 2010-05-26
- Regulation
- 862.1150
- Classification name
- Calibrator, Multi-analyte Mixture
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Susan Hollandbeck
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 3013660430
- 3003795116
- 3003030793
- 9610806
- 9680746
- 2432235
- 9610529
- 1832216
- 3009473156
- 8040374
- 3007662974
- 2026994
- 1717966
- 9610746
- 3002807968
- 3016438761
- 3013513377
- 3012471076
- 2085064
- 3003871639
- 8020888
- 3009448641
- 1319681
- 1219029
- 3000308930
- 3000148879
- 3010127294
- 3006644620
- 9614373
- 2084025
- 3004192065
- 3005094123
- 3009984016
- 2431530
- 9610633
- 1220477
- 3005333358
- 3003741796
- 1319809
- 3010939897
- 3002809144
- 1000403749
- 8032314
- 2032087
- 2247288
- 3004493545
- 3007490412
- 1000256526
- 9681753
- 3007111389
- 1218959
- 3009880320
- 3003593973
- 3032705
- 8020316
- 3023437
- 2050012
- 3010324880
- 2250051
- 2182595
- 3003971136
- 1036362
- 2517506
- 3011989923
- 3002637618
- 3003637681
- 3012348571
- 3002642396
- 2050010
- 2032900
- 1219913
- 3005625991
- 9616673
- 3006198300
- 2030861
- 1181121
- 8030478
- 3003539867
- 3003522182
- 3003951180
Source Documents#
Other 510(k) Records For Product Code JIX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K161140 | VITROS Chemistry Products Calibrator Kit 3 | Ortho-Clinical Diagnostics, Inc. | 2016-05-20 |
| K153365 | ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator | Siemens Healthcare Diagnostics, Inc. | 2015-12-18 |
| K151552 | ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II | Elitechgroup | 2015-07-08 |
| K140790 | Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) | Siemens Healthcare Diagnostics | 2015-06-15 |
| K141388 | SYSTEM CALIBRATER | Beckman Coulter Ireland, Inc. | 2014-07-11 |
| K133330 | C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN | Roche Diagnostics | 2013-11-26 |
| K130765 | ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II | Elitechgroup | 2013-04-04 |
| K123321 | DIMENSION CHEMISTRY III CALIBRATORY | Siemens Healthcare Diagnostics | 2013-02-15 |
| K123372 | ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR | Abbott Laboratories | 2013-01-14 |
| K122398 | RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS | Siemens Healthcare Diagnostics, Inc. | 2012-10-12 |
| K112834 | MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES | Verichem Laboratories, Inc. | 2012-03-28 |
| K112029 | ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 | Elitechgroup | 2011-08-30 |
| K110394 | ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) | Vital Diagnostics (Manufacturing) Ptyltd | 2011-06-09 |
| K110251 | SYNCHRON MULTI CALIBRATOR | Beckman Coulter, Inc. | 2011-05-25 |
| K103701 | ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS | Siemens Healthcare Diagnostics, Inc. | 2011-02-18 |
Legacy Summary#
summary
FDA Review#
Decision Summary