cobas u 701 microscopy analyzer
FDA 510(k) clearance K200811 · decided 2020-11-06
Clearance details
- K-number
- K200811
- Device name
- cobas u 701 microscopy analyzer
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2020-03-27
- Decision date
- 2020-11-06
- Days to decision
- 224 days
- Clearance type
- Traditional
- Product code
- LKM
- Device class
- 2
- Regulation number
- 864.5200
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Roche Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| iQ200 Series (K252580) | Beckman Coulter, Inc. | 2025-09-10 |
| AUTION EYE AI-4510 Urine Particle Analysis System (K232416) | Arkray, Inc. | 2024-05-03 |
| iQ200 System, iChemVELOCITY Automated Urine Chemistry System (K210127) | Beckman Coulter, Inc. | 2021-07-02 |
| Sysmex UF-5000 Fully Automated Urine Particle Analyzer (K171883) | Sysmex America, Inc. | 2018-04-23 |
| IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE (K093861) | Iris International, Inc. | 2010-02-05 |
| SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER (K083002) | Sysmex America, Inc. | 2009-02-03 |
| SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE (K080887) | Sysmex America, Inc. | 2008-05-02 |
| SYSMEX MODEL UF1000I (K070910) | Sysmex America, Inc. | 2007-05-25 |
| SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER (K053135) | Sysmex America, Inc. | 2006-01-04 |
| IQ 200 SYSTEM (K022774) | Intl. Remote Imaging Systems | 2002-10-21 |
| SYSMEX UF-50 (K012372) | Sysmex Corp. | 2001-09-28 |
| 939UDX URINE PATHOLOGY SYSTEM (K000373) | Intl. Remote Imaging Systems | 2000-04-14 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S007) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S006) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs / Elecsys HBs II (P190034/S009) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs II (P190034/S008) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBe (P190005/S005) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007) | Roche Diagnostics | 2024-07-23 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005) | Roche Diagnostics | 2024-05-01 |