510(k) K242767
- Device
- Safecare Urinary Tract Infection Test
- Applicant
- Safecare Biotech (Hangzhou) Co., Ltd.
- 510(k) number
- K242767
- Product code
- JMT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-01-10
- Date received
- 2024-09-13
- Regulation
- 862.1510
- Classification name
- Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Selina Zhang
- Address
- 18 Haishu Rd., Yuhang District Hangzhou CN 311121 311121
FDA Registration Numbers#
- 9611444
- 3003795116
- 9710094
- 3043127647
- 4580
- 3008524085
- 9680746
- 2432235
- 1832216
- 8040374
- 3017591220
- 3043127699
- 3010852191
- 3030648160
- 9615507
- 3016712364
- 1518939
- 3008517993
- 1832816
- 3012073813
- 3024171133
- 3003422726
- 2029372
- 3009448641
- 3005841640
- 3004192065
- 9610633
- 3004043187
- 3013545943
- 3007301207
- 3003741796
- 3013077867
- 3015341499
- 3014759506
- 3025041446
- 1061932
- 3018126397
- 3014255036
- 3003917514
- 3008058135
- 2030633
- 3015729142
- 3012725363
- 3012187283
- 3014055375
- 3038206980
- 3010324880
- 3031915160
- 1221895
- 1649661
- 3006621318
- 1036362
- 3042471840
- 1417592
- 1719513
- 3002637618
- 3003791481
- 3008987086
- 3009238284
- 3010891909
- 3012494290
- 3027519599
- 3013167221
- 3006198300
- 3005360469
- 1181121
- 3013679502
- 2244821
- 3024463179
- 3030446844
- 2122870
- 3021186226
- 3003896222
- 2531491
- 1616487
- 9610126
- 3012421607
Source Documents#
Other 510(k) Records For Product Code JMT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251800 | Healgen® URS Test Strips | Healgen Scientific,, LLC | 2025-12-23 |
| K252607 | AllTest Urinary Tract Infection Test | Hangzhou AllTest Biotech Co., Ltd. | 2025-10-30 |
| K170118 | Scanostics UTI Check Application Test System | Teco Diagnostics | 2017-09-21 |
| K100024 | TECO DIAGNOSTICS UTI DETECTION STRIPS | Teco Diagnostics | 2011-02-17 |
| K993850 | URINALYSIS REAGENT STRIPS (10 PARAMETERS) | International Newtech Development, Inc. | 2000-01-03 |
| K990873 | DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE | Ameritek, Inc. | 1999-09-01 |
| K954685 | URITEST - NITRITE IN URINE TEST | Tcpi, Inc. | 1996-07-22 |
| K960888 | CHEK-STIX U.T.I. SELF-TEST | Bayer Corp. | 1996-07-05 |
| K953672 | FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS | Polymer Technology Intl. | 1996-07-01 |
| K875248 | BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS | Bioscan Instruments, Inc. | 1988-02-24 |
| K855238 | BIOTEL (TM)/UTI | American Diagnostic Corp. | 1986-05-09 |
| K840828 | KYOTEST 8V | Kyoto Diagnostics, Inc. | 1984-05-14 |