Panels › Hematology › Product code LJX · Class 1
Test, Urine Leukocyte
Regulation 864.7675
0510(k)s in 12 months (7 all time)
3recalls in 12 months (5 all time)
2recalls that name a 510(k)
Top companies in LJX
| Company | 510(k)s | Recalls |
|---|---|---|
| Miles Laboratories, Inc. | 2 | 0 |
| ACON Laboratories, Inc. | 1 | 0 |
| ARKRAY USA INC. | 0 | 1 |
| Beckman Coulter Inc. | 0 | 1 |
| Changchun Wancheng Bio-Electron Co., Ltd. | 0 | 1 |
| Chronimed, Inc. | 1 | 0 |
| DFI Co., Ltd. | 0 | 1 |
| Dia-Screen Corp. | 1 | 0 |
| GET TESTED INTERNATIONAL AB | 0 | 1 |
| Healgen Scientific,, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 16, 2023 | K231045 | Healgen URS Test Strips Healgen Scientific,, LLC | LJX |
| Oct 12, 2007 | K063295 | ACON UTI URINARY TRACT INFECTION TEST STRIPS ACON Laboratories, Inc. | LJX |
| May 5, 2000 | K000578 | SERIM LEUKOCYTE ESTERASE TEST STRIPS Serim Research Corp. | LJX |
| Jun 1, 1998 | K981555 | DIASCREEN REAGENT STRIPS Chronimed, Inc. | LJX |
| Jun 17, 1997 | K971976 | DIASCREEN REAGENT STRIPS Dia-Screen Corp. | LJX |
| Sep 11, 1987 | K873304 | CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) Miles Laboratories, Inc. | LJX |
| Jan 4, 1985 | K843727 | LEUKOSTIX REAGENT STRIPS FOR URINALYSIS Miles Laboratories, Inc. | LJX |
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