FDA 510(k) Premarket Notification K252550: SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx

Submission Details & Decision

Normalized public record details for 510(k) notification K252550.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K252550

Applicant / Sponsor

Guangzhou Wondfo Biotech Co., Ltd.

Device Name

SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx

Product Code

NFT

Decision Date

2025-11-18

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Toxicology (TX)

Clearance Type

Traditional

Third Party Flag

Date Received

2025-08-13

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