FDA 510(k) Premarket Notification K241317: Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)

Submission Details & Decision

Normalized public record details for 510(k) notification K241317.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K241317

Applicant / Sponsor

Guangzhou Wondfo Biotech Co., Ltd.

Device Name

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)

Product Code

QYT

Decision Date

2024-09-30

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Microbiology (MI)

Clearance Type

Traditional

Third Party Flag

Date Received

2024-05-10

Related Establishments / Registrations

Ortho-Clinical Diagnostics, Inc. Registration: 1528450 View Registration
ACON LABORATORIES, INC. Registration: 2531491 View Registration
OSANG Healthcare CO., LTD. Registration: 3004146366 View Registration
GUANGZHOU WONDFO BIOTECH CO., LTD. Registration: 3004635103 View Registration
WONDFO USA CO., LTD. Registration: 3007606081 View Registration
ZHEJIANG ORIENT GENE BIOTECH Registration: 3008517993 View Registration
Andon Medical co., LTD Registration: 3008573045 View Registration
HEALGEN SCIENTIFIC LLC Registration: 3009238284 View Registration
ASSURE TECH. (HANGZHOU) CO., LTD. Registration: 3009585529 View Registration
RR Donnelley Global Turnkey Solutions Registration: 3013160357 View Registration
GENBODY INC. Registration: 3014660585 View Registration
GENABIO DIAGNOSTICS INC Registration: 3016609999 View Registration
MAQ-OPS, S. DE R.L. Registration: 3017550662 View Registration
Abbott Diagnostics Scarborough, Inc. Registration: 3017662853 View Registration
OSANG LLC Registration: 3020885868 View Registration
Ortho-Clinical Diagnostics, Inc. Registration: 3021090658 View Registration
GUANGZHOU WONDFO BIOTECH CO., LTD. Registration: 3023322455 View Registration
Access Bio, Inc. Registration: 3024756665 View Registration
HIAN (HONG KONG) CO., LIMITED Registration: 3028107593 View Registration
ASSURE TECH LLC Registration: 3030648160 View Registration
CorDx, Inc. Registration: 3031823359 View Registration
Acon Biotech (Hangzhou) Co., Ltd. Registration: 3032171519 View Registration
INBIOS INTERNATIONAL, INC. Registration: 3032562 View Registration
Ortho-Clinical Diagnostics, Inc. Registration: 3033751096 View Registration
ACON BIOTECH (HANGZHOU) CO., LTD. Registration: 9615507 View Registration

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