510(k) K183432
- Device
- Cobas U 601 Urinalysis Test System
- Applicant
- Roche Diagnostics
- 510(k) number
- K183432
- Product code
- JIL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-05-07
- Date received
- 2018-12-11
- Regulation
- 862.1340
- Classification name
- Method, Enzymatic, Glucose (urinary, Non-quantitative)
- 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
- Angela Clements
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 9611444
- 3006198300
- 3005360469
- 9610633
- 3003795116
- 9710094
- 1181121
- 4580
- 3004043187
- 9680746
- 3007301207
- 3003741796
- 3010324880
- 2432235
- 1832216
- 2244821
- 1649661
- 3038419886
- 8040374
- 3006621318
- 1036362
- 3011121740
- 3030446844
- 2250030
- 2122870
- 3021186226
- 1417592
- 3042471840
- 3002637618
- 1061932
- 9615507
- 3012118659
- 3008517993
- 1832816
- 3009238284
- 3010891909
- 2531491
- 3003422726
- 3003917514
- 1616487
- 3008058135
- 1000414342
- 9610126
- 2029372
- 3012494290
- 2030633
- 1810909
- 3009448641
- 3012421607
- 3005841640
- 3004192065
Source Documents#
Other 510(k) Records For Product Code JIL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K193514 | AUTION MAX AX-4060 Urinalysis System | Arkray, Inc. | 2023-04-13 |
| K173327 | DIP/U.S. Urine Analysis Test System | Healthy.Io, Ltd. | 2018-07-18 |
| K180356 | inui In-Home Urine Analysis Test System | Scanadu, Inc. | 2018-05-25 |
| K181024 | DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips | DFI Co., Ltd. | 2018-05-23 |
| K171521 | DUS R-50S (Urine Chemistry system) | DFI Co., Ltd. | 2018-02-16 |
| K171083 | iChemVELOCITY Automated Urine Chemistry System | Iris Diagnostics, A Division of Iris International, Inc. | 2017-05-12 |
| K160062 | AUTION ELEVEN Semi-Automated Urinalysis System | Arkray, Inc. | 2016-10-07 |
| K160372 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | Teco Diagnostics, Inc. | 2016-07-22 |
| K141289 | TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS | Teco Diagnostics | 2015-07-24 |
| K131600 | URS-2GP (GLUCOSE PROTEIN) URINE STRIPS | Teco Diagnostics | 2014-05-29 |
| K120124 | FORESIGHT U120 URINE ANALYZER | ACON Laboratories, Inc. | 2012-03-06 |
| K101673 | URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 | Teco Diagnostics | 2011-02-04 |
| K091216 | CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797 | Siemens Healthcare Diagnostics | 2009-10-09 |
| K061812 | COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005 | Analyticon Biotechnologies AG | 2007-04-06 |
| K061846 | COMBI SCAN100 | Analyticon Biotechnologies AG | 2007-04-06 |
Legacy Summary#
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FDA Review#
Decision Summary