WEIHAI KANGZHOU BIOTECHNOLOGY ENGINEERING CO., LTD.

FDA Device Registration & Listing · Weihai Shandong, CN · Registration 3014171027

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014171027
FEI Number
3014171027
Entity Name
WEIHAI KANGZHOU BIOTECHNOLOGY ENGINEERING CO., LTD.
City/State/Country
Weihai Shandong, CN
Establishment Address
(Room 401-402, Building B, Innovation Base) No. 213-3, Huoju Road,, Weihai Shandong 264205, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Weihai Kangzhou Biotechnology Engineering Co., Ltd. (Owner Number: 10056397)
Owner / Operator Contact Address
(Room 401-402, Building B, Innovation Base) No. 213-3, Huoju Road,, Weihai, CN-SD 264205, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K183097
PMA Number
N/A

All Registered Proprietary Names

marijuana test strip/cassette/cup One Step hCG Test Strip, One Step hCG Test Cassette, One Step hCG Test Midstream U Pregnancy Test MaYa One Step HCG Pregnancy Test

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PVJ Test, Cannabinoid, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3870 2018-04-26
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2019-01-15

Official Correspondent

No official correspondent registered.

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Weihai Kangzhou Biotechnology Engineering Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K964108 Direct Access Diagnostics FACT PLUS PREGNANCY TEST 1996-11-18
K945514 Princeton BioMeditech Corp. LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG 1995-02-10
K150022 Guangzhou Wondfo Biotech Co., Ltd. Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream 2015-08-07
K043443 Guangzhou Wondfo Biotech Co., Ltd. ONE STEP HCG URINE PREGNANCY TEST 2005-04-08
K173229 Guangzhou Wondfo Biotech Co., Ltd. Preview Digital Pregnancy Test 2018-03-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0042-2024 Universal Meditech Inc. 2
One Step Pregnancy Test REF 100-01

Similar Registrations

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3011522054 Hangzhou Biotest Biotech Co.,Ltd. Hangzhou Zhejiang, CN
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3008852306 Chemtron Biotech, Inc. San Diego, CA, US
3009238284 HEALGEN SCIENTIFIC LLC Houston, TX, US
3027693054 ORFILA DIAGNOSTICS INC. DBA NFORM Wilmington, DE, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014171027. Last updated year: 2026. Please use registration number 3014171027 when referencing this establishment in official correspondence.
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