LJX — Test, Urine Leukocyte Class I
FDA Device Classification
Classification Details
- Product Code
- LJX
- Device Class
- Class I
- Regulation Number
- 864.7675
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K231045 | healgen scientific | Healgen URS Test Strips | June 16, 2023 |
| K063295 | acon laboratories | ACON UTI URINARY TRACT INFECTION TEST STRIPS | October 12, 2007 |
| K000578 | serim research | SERIM LEUKOCYTE ESTERASE TEST STRIPS | May 5, 2000 |
| K981555 | chronimed | DIASCREEN REAGENT STRIPS | June 1, 1998 |
| K971976 | dia-screen | DIASCREEN REAGENT STRIPS | June 17, 1997 |
| K873304 | miles laboratories | CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) | September 11, 1987 |
| K843727 | miles laboratories | LEUKOSTIX REAGENT STRIPS FOR URINALYSIS | January 4, 1985 |