FDA Product Code
FDA Product Code LJX — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7675
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K231045 | Healgen URS Test Strips | Healgen Scientific,, LLC | 2023-06-16 | Traditional | PDF ↗ |
| K063295 | ACON UTI URINARY TRACT INFECTION TEST STRIPS | ACON Laboratories, Inc. | 2007-10-12 | Traditional | PDF ↗ |
| K000578 | SERIM LEUKOCYTE ESTERASE TEST STRIPS | Serim Research Corp. | 2000-05-05 | Traditional | PDF ↗ |
| K981555 | DIASCREEN REAGENT STRIPS | Chronimed, Inc. | 1998-06-01 | Traditional | PDF ↗ |
| K971976 | DIASCREEN REAGENT STRIPS | Dia-Screen Corp. | 1997-06-17 | Traditional | PDF ↗ |
| K873304 | CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) | Miles Laboratories, Inc. | 1987-09-11 | Traditional | PDF ↗ |
| K843727 | LEUKOSTIX REAGENT STRIPS FOR URINALYSIS | Miles Laboratories, Inc. | 1985-01-04 | Traditional | PDF ↗ |
Product code LJX · Class I · Hematology. Data: openFDA.