510(k) K063295
- Device
- ACON UTI URINARY TRACT INFECTION TEST STRIPS
- Applicant
- ACON LABORATORIES, INC.
- 510(k) number
- K063295
- Product code
- LJX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-10-12
- Date received
- 2006-11-01
- Regulation
- 864.7675
- Classification name
- Test, Urine Leukocyte
- Medical specialty
- Hematology
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JINN-NAN LIN
- Address
- 4108 Sorrento Valley Blvd. San Diego CA US 92121 92121
FDA Registration Numbers#
- 3005841640
- 3009238284
- 3042471840
- 1833387
- 3006198300
- 9610633
- 3030648160
- 4580
- 3013077867
- 3013679502
- 3003917514
- 2030633
- 3012187283
- 3038206980
- 3012725363
- 1649661
- 3008987086
- 3008058135
- 3010852191
- 2029372
- 1221895
- 3003795116
- 3021186226
- 3010891909
- 1832816
- 3015341499
- 3002637618
- 1832216
- 1518939
- 3012421607
- 3031915160
- 2432235
- 8040374
- 3004192065
- 3011689956
- 1719513
- 3027519599
- 3003896222
- 9680746
- 9710094
- 1616487
- 1417592
- 3007301207
- 3043127699
- 2244821
- 3010324880
- 1181121
- 3008517993
- 3012073813
- 3005360469
- 3003791481
- 2028411
- 3025041446
- 3017591220
- 3016712364
- 3020956494
- 2531491
- 3043127647
- 3003422726
- 3012706495
- 9615507
- 3018126397
- 3009448641
- 3013545943
- 9611444
- 9610126
- 1036362
- 3016609999
- 3006621318
- 3007126977
- 3030446844
- 3024463179
- 3024171133
- 3012494290
- 3014255036
- 2122870
- 1061932
- 3014759506
- 3015729142
- 3004043187
Source Documents#
Other 510(k) Records For Product Code LJX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231045 | Healgen URS Test Strips | Healgen Scientific,, LLC | 2023-06-16 |
| 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 |
Legacy Summary#
summary
FDA Review#
Decision Summary