Test, Urine Leukocyte
Test, Urine Leukocyte is a diagnostic test used to detect the presence of leukocytes (white blood cells) in urine, which can indicate urinary tract infection, kidney disease, or other conditions involving inflammation of the urinary tract. This device is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is LJX, regulated under 21 CFR 864.7675, within the Hematology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LJX
- Device Class
- FDA class 1
- Regulation Number
- 864.7675
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K231045 | Healgen URS Test Strips | Jun 16, 2023 | Substantially Equivalent | Healgen Scientific,, LLC |
| K063295 | ACON UTI URINARY TRACT INFECTION TEST STRIPS | Oct 12, 2007 | Substantially Equivalent | ACON Laboratories, Inc. |
| K000578 | SERIM LEUKOCYTE ESTERASE TEST STRIPS | May 05, 2000 | Substantially Equivalent | Serim Research Corp. |
| K981555 | DIASCREEN REAGENT STRIPS | Jun 01, 1998 | Substantially Equivalent | Chronimed, Inc. |
| K971976 | DIASCREEN REAGENT STRIPS | Jun 17, 1997 | Substantially Equivalent | Dia-Screen Corp. |
| K873304 | CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) | Sep 11, 1987 | Substantially Equivalent | Miles Laboratories, Inc. |
| K843727 | LEUKOSTIX REAGENT STRIPS FOR URINALYSIS | Jan 04, 1985 | Substantially Equivalent | Miles Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 83 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 83 registration numbers. Click on an entry to view related FDA registrations.