Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032171519

FEI Number

3032171519

Entity Name

Acon Biotech (Hangzhou) Co., Ltd.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

Qingshanhu Subdistrict, Linan District, Hangzhou Zhejiang 311305, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ACON Laboratories Inc. (Owner Number: 9033096)

Owner / Operator Contact Address

5850 Oberlin Drive, #340, San Diego, CA 92121, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QYT	Over-The-Counter Covid-19 Antigen Test	Microbiology	Class 2	866.3984	2024-06-26
QMN	Covid-19 Multi-Analyte Antigen Device	Unknown	Class N	N/A	2024-07-23

Official Correspondent

Catherine Shi

US Agent Details

Catherine Shi Business: ACON LABORATORIES INC. Email: cshi@aconlabs.com Phone: (858) 8758068

Related Public Records

Same Entity

ACON Laboratories Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9615507	ACON BIOTECH (HANGZHOU) CO., LTD.	HANGZHOU Zhejiang, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K241317	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)	2024-09-30

Similar Registrations

Registration Number	Establishment Name	Location
3033751096	Ortho-Clinical Diagnostics, Inc.	San Diego, CA, US
3004635103	GUANGZHOU WONDFO BIOTECH CO., LTD.	Guangzhou Guangdong, CN
3021090658	Ortho-Clinical Diagnostics, Inc.	Carlsbad, CA, US
3004146366	OSANG Healthcare CO., LTD.	ANYANG Gyeonggi, KR
3023322455	GUANGZHOU WONDFO BIOTECH CO., LTD.	Guangzhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032171519. Last updated year: 2026. Please use registration number 3032171519 when referencing this establishment in official correspondence.