Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018187017

FEI Number

3018187017

Entity Name

BIOSYNCHRONICITY CORPORATION

City/State/Country

Bellevue, WA, US

Establishment Address

325 118th Avenue SE, Ste 210, Bellevue, WA 98005, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BioSynchronicity Corporation (Owner Number: 10080707)

Owner / Operator Contact Address

325 118th Ave SE, Ste 210, Bellevue, WA 98005, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

C-Sync COVID-19 Antigen Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2021-02-25

Official Correspondent

Muriel Wood

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BioSynchronicity Corporation

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2023	Jiangsu Well Biotech Co., Ltd. No	N	Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018187017. Last updated year: 2026. Please use registration number 3018187017 when referencing this establishment in official correspondence.