939UDX URINE PATHOLOGY SYSTEM
FDA 510(k) clearance K000373 · decided 2000-04-14
Clearance details
- K-number
- K000373
- Device name
- 939UDX URINE PATHOLOGY SYSTEM
- Applicant
- Intl. Remote Imaging Systems
- Decision
- Substantially Equivalent
- Date received
- 2000-02-04
- Decision date
- 2000-04-14
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- LKM
- Device class
- 2
- Regulation number
- 864.5200
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Chatsworth, CA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| 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 |
Recalls involving this device
No recalls on record reference this clearance.