510(k) K202453
- Device
- SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
- Applicant
- Safecare Biotech(Hangzhou)Co.,Ltd.
- 510(k) number
- K202453
- Product code
- NFT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-03-24
- Date received
- 2020-08-27
- Regulation
- 862.3100
- Classification name
- Test, Amphetamine, Over The Counter
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Alex Qiu
- Address
- Bldg. 2/203 #18 Haishu Rd., Cangqian Sub-District Yuhang District Hangzhou CN 311121 311121
FDA Registration Numbers#
- 1910144
- 3012725363
- 3014301129
- 3006048451
- 3015821396
- 3005360469
- 3036649420
- 3043127647
- 2087033
- 3011522054
- 3009414546
- 3007606081
- 3009585529
- 3023296261
- 3030413233
- 3010934853
- 3017904598
- 2060833
- 3013077867
- 3005345870
- 3008741972
- 1649661
- 3010220539
- 3016447251
- 3032147516
- 3024463179
- 3021186226
- 3010852191
- 3025041446
- 3043196750
- 3030648160
- 3024753119
- 3008517993
- 3012073813
- 3005984081
- 3009238284
- 3013223546
- 3038614708
- 3003917514
- 3004635103
- 3031697086
- 3014223276
- 2029372
- 2030633
- 3009212837
- 3025349997
- 3027519599
- 3023322455
Source Documents#
Other 510(k) Records For Product Code NFT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261280 | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel | Vivachek Biotech (Hangzhou) Co., Ltd. | 2026-05-22 |
| K260065 | SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx | Guangzhou Wondfo Biotech Co., Ltd. | 2026-04-28 |
| K260355 | Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup | WEBEST Biotech,, LLC | 2026-03-09 |
| K252550 | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx | Guangzhou Wondfo Biotech Co., Ltd. | 2025-11-18 |
| K252867 | VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup | Advin Biotech, Inc. | 2025-10-09 |
| K252554 | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup | Vivachek Biotech (Hangzhou) Co., Ltd. | 2025-09-12 |
| K252118 | CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup | Hangzhou Clongene Biotech Co., Ltd. | 2025-08-27 |
| K252259 | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup | Assure Tech., LLC | 2025-08-15 |
| K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2025-04-04 |
| K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2025-02-27 |
| K243996 | AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup | Assure Tech., LLC | 2025-02-07 |
| K242498 | Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC | Aicheck Biotech, Inc. | 2024-10-01 |
| K242540 | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel | Hangzhou AllTest Biotech Co., Ltd. | 2024-09-27 |
| K242077 | PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup | Aicheck Biotech, Inc. | 2024-08-14 |
| K241428 | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2024-06-17 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases