Product code LJX
- Device name
- Test, Urine Leukocyte
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.7675
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231045 | Healgen URS Test Strips | Healgen Scientific,, LLC | 2023-06-16 |
| K063295 | ACON UTI URINARY TRACT INFECTION TEST STRIPS | ACON Laboratories, Inc. | 2007-10-12 |
| K000578 | SERIM LEUKOCYTE ESTERASE TEST STRIPS | Serim Research Corp. | 2000-05-05 |
| K981555 | DIASCREEN REAGENT STRIPS | Chronimed, Inc. | 1998-06-01 |
| K971976 | DIASCREEN REAGENT STRIPS | Dia-Screen Corp. | 1997-06-17 |
| K873304 | CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) | Miles Laboratories, Inc. | 1987-09-11 |
| K843727 | LEUKOSTIX REAGENT STRIPS FOR URINALYSIS | Miles Laboratories, Inc. | 1985-01-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10612479279886 | Mckesson | MCKESSON MEDICAL-SURGICAL INC. | 2025-09-18 |
| 10673486000528 | Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System | TECO DIAGNOSTICS | 2024-06-06 |
| 10673486000511 | Teco Diagnostics Uritek TC-201 Urine Chemistry Test System | TECO DIAGNOSTICS | 2024-06-04 |
| 08806141302209 | Just Fitter 10 Parameter Test Strips | DFI CO.,LTD | 2020-09-22 |
| 08806141302070 | CYBOW 10 | DFI CO.,LTD | 2020-06-29 |
| 10673486000672 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2020-03-09 |
| 08806141301998 | Yodoc 10 | DFI CO.,LTD | 2020-02-20 |
| 10673486000665 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2019-05-06 |
| 10673486000658 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2019-05-06 |
| 08806141301479 | QTEST™ 11 | DFI CO.,LTD | 2018-12-21 |
| 10722355002924 | Detector UA 10SG | Immunostics Company, Inc | 2018-11-20 |
| 10722355002917 | Detector UA 2GP | Immunostics Company, Inc | 2018-11-20 |
| 10673486000610 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2018-03-27 |
| 10673486000450 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2018-01-08 |
| 10673486000535 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2018-01-04 |
| 08806125680286 | UCARE 11 Stick | YD Diagnostics CORP. | 2017-07-28 |
| 08806125680279 | UCARE 11 Stick | YD Diagnostics CORP. | 2017-07-28 |
| 08806125680217 | URiSCAN 10 SGL strip | YD Diagnostics CORP. | 2016-12-21 |
| 08806141300755 | CYBOW 11 | DFI CO.,LTD | 2016-10-06 |
| 10673486000054 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000078 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000061 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000047 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000030 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000023 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000016 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10722355002221 | Detector UA 10 | Immunostics Company, Inc | 2016-09-26 |
| 10722355002238 | Detector UA 5 | Immunostics Company, Inc | 2016-09-25 |
| 08806125680064 | URiSCAN 6 L strip | YD Diagnostics CORP. | 2016-09-01 |
| 08806125680019 | URiSCAN 10 SGL strip | YD Diagnostics CORP. | 2016-08-05 |