Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx
FDA 510(k) clearance K221871 · decided 2022-08-30
Clearance details
- K-number
- K221871
- Device name
- Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx
- Applicant
- Healstone Biotech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-06-28
- Decision date
- 2022-08-30
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- NFT
- Device class
- 2
- Regulation number
- 862.3100
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Vancouver, CA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup (K261984) | Assure Tech., LLC | 2026-07-17 |
| BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel (K261280) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2026-05-22 |
| SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx (K260065) | Guangzhou Wondfo Biotech Co., Ltd. | 2026-04-28 |
| Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup (K260355) | WEBEST Biotech,, LLC | 2026-03-09 |
| SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx (K252550) | Guangzhou Wondfo Biotech Co., Ltd. | 2025-11-18 |
| VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup (K252867) | Advin Biotech, Inc. | 2025-10-09 |
| Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup (K252554) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2025-09-12 |
| CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup (K252118) | Hangzhou Clongene Biotech Co., Ltd. | 2025-08-27 |
| AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup (K252259) | Assure Tech., LLC | 2025-08-15 |
| AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup (K250727) | Hangzhou AllTest Biotech Co., Ltd. | 2025-04-04 |
| AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup (K244043) | Hangzhou AllTest Biotech Co., Ltd. | 2025-02-27 |
| AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup (K243996) | Assure Tech., LLC | 2025-02-07 |
Recalls involving this device
No recalls on record reference this clearance.