FDA 510(k) Premarket Notification K202567: Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx

Submission Details & Decision

Normalized public record details for 510(k) notification K202567.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K202567

Applicant / Sponsor

Guangzhou Wondfo Biotech Co., Ltd.

Device Name

Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx

Product Code

NFT

Decision Date

2020-09-25

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Toxicology (TX)

Clearance Type

Traditional

Third Party Flag

Date Received

2020-09-04

Related Establishments / Registrations

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JANT PHARMACAL CORP. Registration: 2030633 View Registration
ALFA SCIENTIFIC DESIGNS, INC. Registration: 2060833 View Registration
W.H.P.M., INC. Registration: 2087033 View Registration
BTNX Inc. Registration: 3003917514 View Registration
GUANGZHOU WONDFO BIOTECH CO., LTD. Registration: 3004635103 View Registration
W.H.P.M. Bioresearch & Technology Co., Ltd. Registration: 3005345870 View Registration
ACRO BIOTECH Inc. Registration: 3005360469 View Registration
LUMIQUICK DIAGNOSTICS, INC. Registration: 3005984081 View Registration
Confirm Biosciences LLC Registration: 3006048451 View Registration
WONDFO USA CO., LTD. Registration: 3007606081 View Registration
ZHEJIANG ORIENT GENE BIOTECH Registration: 3008517993 View Registration
Lochness Medical Registration: 3008741972 View Registration
MEDICAL DISPOSABLES CORP Registration: 3009212837 View Registration
HEALGEN SCIENTIFIC LLC Registration: 3009238284 View Registration
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ASSURE TECH. (HANGZHOU) CO., LTD. Registration: 3009585529 View Registration
CO-INNOVATION BIOTECH CO.,LTD. Registration: 3010220539 View Registration
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ADVIN BIOTECH, INC. Registration: 3010934853 View Registration
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EASY HEALTHCARE CORPORATION Registration: 3012725363 View Registration
SAFECARE BIOTECH(HANGZHOU)CO.,LTD Registration: 3013077867 View Registration
VIVACHEK BIOTECH (HANGZHOU) CO., LTD Registration: 3013223546 View Registration
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ACESO LABORATORIES INC. Registration: 3024463179 View Registration
BOSTON EASY BIOTECH INC Registration: 3024753119 View Registration
2SAN LLC Registration: 3025041446 View Registration
HANGZHOU AICHEK MEDICAL TECHNOLOGY CO., LTD. Registration: 3025349997 View Registration
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KEVA INC. Registration: 3043196750 View Registration

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